Overview The primary responsibility of this position is to support / lead on the design, development and taking to market of medical devices for Cook Medical. Position: Research & Development Engineer 2 Reporting to: Team Lead, Research and Development / Manager, Research and Development Responsibilities Perform Duties of Research & Development Engineer 2: Design development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner. Product testing and evaluation, completion of test reports to support design selection. Preparation and presentation of design reviews. Product risk analysis and risk management. Contribute towards process development during introduction /development of new equipment and production processes as required for any new manufacturing techniques. Source new materials components and equipment. Development of component specifications, inspection methods, bills of materials and manufacturing processes. Introduction of new equipment, materials and technologies. As required work closely with Key Opinion Leaders, physicians, product managers and team to develop innovative medical devices to improve patient care. Work closely with Project Lead and take responsibility for assigned research and development project tasks: Manage and drive assigned project tasks to ensure timely completion of project milestones. Work closely with cross functional groups to achieve project and company goals. Product performance evaluations. Contribute to innovation and creativity within team through filing of disclosures and patents. Hold regular project meetings and document minutes and actions. Ensure project milestones are achieved to meet business metrics. Communications: Regular communication to cross-functional teams and senior management. Project status communications and reporting. Remain on the forefront of emerging industry practices. Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products. Support other cross functional groups to deliver company goals. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Bachelor's degree is required, preferably in engineering or a related field. Minimum of 3 years' relevant experience is desired. Project planning/execution skills. Execution of project in a timely effective manner. Knowledge of anatomy and physiology. Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge. Statistical understanding and experience. Manufacturing design and process understanding. Good working knowledge of Solidworks and/or Pro Engineer CAD. Strong technical writer. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. Willingness and availability to travel on company business. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid #LI-RM1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The Director of Post Market Quality Assurance (PMQA) is responsible for ensuring the effectiveness and compliance of complaints, adverse event reports, recalls, and related post market processes within the global corporate quality management system. This role provides leadership and direction to global Quality Assurance teams by inspiring international teams, fostering a culture of collaboration, accountability, and high performance to ensure consistent delivery of centralized capabilities across all markets, leading to positive customer experiences. Responsibilities Direct and maintain a scalable, global structure for post market quality assurance ensuring clear communication and alignment with regional regulatory needs and business objectives. Develop and lead strategic vision and objectives for the global post market quality assurance team, ensuring alignment with overall corporate goals, regulatory requirements, and operational excellence initiatives. Collaborate closely with global functional leadership to ensure local market needs are integrated into global strategies. Provide leadership and mentorship and technical expertise to a diverse geographically dispersed post market quality assurance team, ensuring alignment with global standards and regional needs. Oversee and manage post market quality assurance budgets, including cost tracking, and strategic planning to support global operational priorities. Oversee and ensure that all post market quality activities comply with applicable regulations, including but not limited to: ISO13485, US FDA CFR Part 820, State Council Order No. 739- China, PMD Act, Law Act 145- Japan, Medical Device Management Act- Taiwan, Medical Devices Act- Korea, Good Distribution Practices-Thailand, etc. Proactively monitor regulatory changes and lead updates to post market quality assurance to maintain compliance. Drive adherence to relevant Quality Management Systems and Business Processes, promoting a culture of quality and organizational effectiveness. Engage effectively with stakeholders across all levels of the global organization, including regional regulatory agencies, to foster strategic relationships, influence policy, and ensure compliance. Lead cross-functional collaboration to optimize post market quality assurance processes. Foster a high-performance culture focused on talent development, succession planning, and continuous improvement. Establish and maintain global best practices, standardised policies, and/or procedural controls as needed to ensure consistency, accuracy and compliance of PMQA work outputs and systems. Balance standardization with regional flexibility where necessary. Champion a continuous improvement culture by leading initiatives that leverage AI and digital tools, automation, and innovate processes to enhance efficiency, accuracy and compliance in PMQA activities. Ensure local and corporate entities fulfil PMQA economic operator roles and responsibilities, including those for in-country representatives. Oversee the health of the PMQA QMS through proactive data collection, trend analysis, and implementation of improvement actions. Direct leadership to ensure compliance of the PMQA QMS with global QA policies, procedures, and direction. Oversee customer complaints, recall, and adverse reporting processes, ensuring appropriate handling, escalation, and resolution by relevant teams Serve as the Global Process Owner and represent Cook during internal and external audits. Represent PMQA globally, participating in working groups and supporting the voice of Cook and patients in industry guidance and regulation commentary Ensure post market quality assurance team members possess the requisite technical skills, experience, and training to perform their work. Provide strategic recommendations for workforce planning and contribute significantly to employee related decisions and development initiatives. Foster and maintain a positive, inclusive and productive work environment aligned with Cook's culture and values. Maintain overall accountability for PMQA QMS performance, communicating effectiveness and improvement needs to executive management and ensuring timely corrective actions. Willingness and availability to travel globally on company business. Qualifications Bachelor's degree or equivalent in Quality, Science or Engineering is required. A minimum of 12 years' experience in a regulated industry in a similar role preferred. Minimum of 8 years management experience leading Quality professionals. Working knowledge and experience applying medical device regulations and standards. ISO13485 and regional regulations for PMDA & TMG, MFDS, TFDA, US FDA, EUMDR, NMPA & SHMPA, and other health authorities desirable. Knowledge and experience of Quality Assurance, Quality Engineering and Regulatory Affairs, manufacturing and distribution operations. Knowledge of customer complaint management and recall management globally. Strong leadership and team management capabilities, with demonstrated success in guiding and developing global teams. Ability to lead and deliver multiple complex global projects simultaneously within deadlines. Ability to develop and maintain strong working relationships with internal and external stakeholders. Adapt to dynamic landscapes and organizational changes, with the ability to adjust quickly and effectively in a change-driven environment. Excellent problem-solving abilities and the capacity to work effectively both collaboratively and independently in environments with minimal supervision. Excellent organizational and planning abilities, complemented by keen attention to detail. Demonstrated ability to work in a fast-paced, high-pressure environment and meet deadlines. Collaborative team player with a proven ability to foster trust, open communication, and effective collaboration across diverse teams and stakeholders. Effective communication and interpersonal skills to build relationships across diverse geographies and cultures. Self-motivated and proactive, with a passion for driving quality and operational excellence. Flexibility to work across global time zones as required. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The primary responsibility of this position is to support / lead on the design, development and taking to market of medical devices for Cook Medical. Reporting to: Team Lead, Research and Development / Manager, Research and Development Find out more about Cook Medical here Responsibilities Perform Duties of Research & Development Engineer 2: Design development, prototyping, test method design, design evaluation , design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner. Product testing and evaluation, completion of test reports to support design selection. Preparation and presentation of design reviews. Product risk analysis and risk management. Contribute towards process development during introduction /development of new equipment and production processes as required for any new manufacturing techniques. Source new materials components and equipment. Development of component specifications, inspection methods, bills of materials and manufacturing processes. Introduction of new equipment, materials and technologies. As required work closely with Key Opinion Leaders, physicians, product managers and team to develop innovative medical devices to improve patient care. Work closely with Project Lead and take responsibility for assigned research and development project tasks: Manage and drive assigned project tasks to ensure timely completion of project milestones. Work closely with cross functional groups to achieve project and company goals. Product performance evaluations. Contribute to innovation and creativity within team through filing of disclosures and patents. Hold regular project meetings and document minutes and actions. Ensure project milestones are achieved to meet business metrics. Communications: Regular communication to cross-functional teams and senior management. Project status communications and reporting. Remain on the forefront of emerging industry practices. Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products. Support other cross functional groups to deliver company goals. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Bachelor's degree is required, preferably in engineering or a related field. Minimum of 3 years' relevant experience is desired. Project planning/execution skills. Execution of project in a timely effective manner. Knowledge of anatomy and physiology. Good mechanical design and understanding of engineering fundamentals with medical device materials knowledge. Statistical understanding and experience. Manufacturing design and process understanding. Good working knowledge of Solidworks and/or Pro Engineer CAD. Strong technical writer. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. Willingness and availability to travel on company business. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The MedSurg R&D team in Limerick has two programs, Endoscopy/EndoSurgery and Otolaryngology Head and Neck Surgery (OHNS) that it is responsible for designing and developing new and innovative products for. The R&D engineers and scientists have the opportunity to explore and create novel ideas within feasibility, bring a medical device through verification and validation phase and be a part of bringing a new product to the market. The MedSurg R&D team works in collaboration with Cook's sister site in Winston Salem, North Carolina. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview Lead Research & Development team in the design, development and taking to market of medical devices for the Cook Vascular division Reporting to: Research & Development Manager or Senior Research & Development Manager Find out more about Cook Medical here Responsibilities Perform Duties of Senior Research & Development Engineer: Design development, prototyping, test method design, design evaluation , design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely and effective manner. Product and project risk analysis and risk management. Develop prototypes which are consistent with the clinical and design requirements of the project. Research new therapies and design solutions to develop and complement the existing product portfolio. Introduce new equipment, materials and technologies. Work closely with Key Opinion Leaders (KOL's), physicians and product managers to develop innovative medical devices to improve patient care. Project lead for assigned Research & Development team/s including technical and project management leadership responsibly. Lead technical development of projects. Lead all key design decisions to ensure quality design selection. Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved. Work closely to build effective relationships with cross functional groups to achieve project and company goals. Retrospective project reviews to understand lessons learned. Manage device evaluations. Compliance with Quality, Regulatory and company policies and systems. Mentoring, coaching and development of direct reports if required. Foster innovation and creativity within team and perform disclosure reviews. Compliance with Quality, Regulatory and company policies and systems. Communications: Regular communication to cross-functional teams, senior management and business unit leaders. Project status communications and reporting. Ensure effective reporting to the R&D Manager or Senior R&D Manager . Remain on the forefront of emerging industry practices. Instrumental in driving and implementing change to improve departmental and company performance. Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products. Support other cross functional groups to deliver company goals. Act as a designee of the Research & Development Manager orr the Senior Test Engineer if required. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications Third level degree in Mechanical, Biomedical, Science, Design or similar discipline, Masters or Ph.D. level preferred but not essential. 5+ years' experience is ideal. Proven Project Leadership abilities. Good Project Management methodology and skills. Proven track record in delivering quality results in a timely effective manner. Knowledge of anatomy and physiology. Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge. Innovative/Creative Engineer. Good manufacturing design and process understanding. Good working knowledge of Solidworks and/or Pro Engineer CAD. Good presentation skills (working knowledge of MS PowerPoint). Strong technical writer. Attention to detail and Quality focus. Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820). Team Player with ability to develop strong working relationships. Strong communication and inter-personal skills. Good problem solving skills. Highly motivated individual, self-starter with a passion for excellence. Must be able to work in a fast paced environment. Ability to foster relationships with key stakeholders required to ensure on time project delivery. Experience of medical device development from concept through to commercialisation. Ability to effectively translate needs of clinicians and SBU into project inputs. Willingness and availability to travel on company business. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Research and Development in Limerick Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world. Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch. The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market. All this is done through collaboration within small or large R&D teams and working with cross functional teams both locally in Limerick and globally with our sister companies. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid #LI-AK1 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
A medical device company in Limerick is seeking a Director of Post Market Quality Assurance to ensure compliance and effectiveness in quality processes. This role involves leading and mentoring a global team, integrating local market needs into strategies, and overseeing the management of complaints and recalls. The ideal candidate will have extensive experience in a regulated environment and possess a Bachelor's degree in a relevant field. The company offers a dynamic work environment with a focus on quality and operational excellence. #J-18808-Ljbffr
Overview The Senior Manager, Biocompatibility participates in the development of and leads the implementation of the global strategy, governance, and compliance of biocompatibility ensuring accuracy and continuous improvement through standardized systems and processes. Leads and inspires global teams, fostering a culture of collaboration, accountability, and high performance to ensure consistent delivery of centralized capabilities across all markets. Responsibilities Responsibility for executing of all activities associated with the biocompatibility assessments, testing and reporting. Direct and maintain a scalable, global structure for biocompatibility ensuring clear communication and alignment with business objectives. Participate in the development of and lead implementation of a strategic vision and objectives for the global Biocompatibility team, ensuring alignment with overall corporate goals, regulatory requirements, and operational excellence initiatives. Collaborate closely with global functional leadership to ensure local market needs are integrated into global strategies. Participate in standards committees to drive best practice in the field of biocompatibility testing. Manage and foster relationship with key suppliers, specifically external biocompatibility test entities. Provide leadership and mentorship and technical expertise to a diverse geographically dispersed Biocompatibility team, ensuring alignment with global standards and regional needs. Oversee and manage biocompatibility budgets, including cost tracking, and strategic planning to support global operational priorities. Drive adherence to relevant Quality Management Systems and Business Processes, promoting a culture of quality and organizational effectiveness. Engage effectively with stakeholders across all levels of the global organization to foster strategic relationships, influence policy, and ensure compliance. Lead cross-functional collaboration to optimize Biocompatibility processes. Foster a high-performance culture focused on talent development, succession planning, and continuous improvement. Establish and maintain global best practices, standardised policies, and/or procedural controls as needed to ensure consistency, accuracy and compliance of biocompatibility work outputs and systems. Balance standardization with regional flexibility where necessary. Champion a continuous improvement culture by leading initiatives that leverage AI and digital tools, automation, and innovate processes to enhance efficiency, accuracy and compliance in biocompatibility activities. Ensure biocompatibility team members possess the requisite technical skills, experience, and training to perform their work. Provide strategic recommendations for workforce planning and contribute significantly to employee related decisions and development initiatives. Foster and maintain a positive, inclusive and productive work environment aligned with Cook's culture and values. Willingness and availability to travel globally on company business. Qualifications Bachelor's degree in Science or Engineering and 10 years' relevant experience. Relevant PhD may reduce the experience requirement by 2-4 years. Experience in a regulated industry in a similar role preferred. Demonstrated experience of executing all aspects of biocompatibility assessment and testing, as well as interacting standards bodies. Strong leadership and team management capabilities, with ability to guide and develop global teams. Ability to lead and deliver multiple complex global projects simultaneously within deadlines. Ability to develop and maintain strong working relationships with internal and external stakeholders. Adapt to dynamic landscapes and organizational changes, with the ability to adjust quickly and effectively in a change-driven environment. Excellent problem-solving abilities and the capacity to work effectively both collaboratively and independently in environments with minimal supervision. Excellent organizational and planning abilities, complemented by keen attention to detail. Demonstrated ability to work in a fast-paced, high-pressure environment and meet deadlines. Collaborative team player with a proven ability to foster trust, open communication, and effective collaboration across diverse teams and stakeholders. Effective communication and interpersonal skills to build relationships across diverse geographies and cultures. Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements, as applicable by country, of: (i) the ADA (Americans with Disabilities Act) (USA Only); (ii) Disability Discrimination Act 1992 (Australia Only); or (iii) other applicable local, regional, or national law or regulation. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The Manager of Drafting manages the compliance of product and equipment modelling and drawings, ensuring accuracy, alignment, and continuous improvement across all teams through standardized systems and processes. Responsibilities Leads a team that creates, modifies, and maintains models, assemblies, and drawings as prescribed by change order. Develop and lead objectives for the global drafting team, ensuring alignment with overall corporate goals and operational excellence initiatives. Lead cross-functional collaboration to optimize drafting processes. Champion a continuous improvement culture by leading initiatives that leverage AI and digital tools, and innovate processes to enhance efficiency, accuracy and compliance in drafting activities. Ensures application of best practices and general drafting standards, such as ASME Y14.5. Establish and maintain global best practices, standardised policies, and/or procedural controls as needed to ensure consistency, accuracy and compliance of drafting work outputs and systems. Ensure collaboration with the systems teams on maintaining the required drafting tools and licences. Develop and maintain and a clear intake process for drawing requests and prioritisation. Apply attention to detail and communication skills in order to collaborate with various groups to finalize updates to clean copies of published drawings taking into account requirements by all functional groups involved. Provide leadership and technical expertise to a diverse geographically dispersed drafting team, ensuring alignment with global standards and regional needs. Drive adherence to relevant Quality Management Systems and Business Processes, promoting a culture of quality and organizational effectiveness. Foster a high-performance culture focused on talent development, succession planning, and continuous improvement. Ensure drafting team members possess the requisite technical skills, experience, and training to perform their work. Provide recommendations for workforce planning and contribute significantly to employee related decisions and development initiatives. Foster and maintain a positive, inclusive and productive work environment aligned with Cook's culture and values. Willingness and availability to travel globally on company business. Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements of the ADA (Americans with Disabilities Act) (US Only) Qualifications Degree in Science and Engineering or other relevant discipline and 7 years relevant experience. Experience in a regulated industry in a similar role preferred. Strong leadership and team management capabilities, with ability to guide and develop global teams. Ability to lead and deliver multiple complex global projects simultaneously within deadlines. Ability to develop and maintain strong working relationships with internal and external stakeholders. Adapt to dynamic landscapes and organizational changes, with the ability to adjust quickly and effectively in a change-driven environment. Excellent problem-solving abilities and the capacity to work effectively both collaboratively and independently in environments with minimal supervision. Excellent organizational and planning abilities, complemented by keen attention to detail. Demonstrated ability to work in a fast-paced, high-pressure environment and meet deadlines. Collaborative team player with a proven ability to foster trust, open communication, and effective collaboration across diverse teams and stakeholders. Effective communication and interpersonal skills to build relationships across diverse geographies and cultures. Self-motivated and proactive, with a passion for driving quality and operational excellence. Flexibility to work across global time zones as required. This role requires fluence in Artificial Intelligence (AI) and data concepts, including the ability to critically evaluate AI outputs, improve workflows using approved tools, identify and mitigate bias or inaccuracies, and communicate AI-driven insights clearly and responsibly to peers and managers. Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements, as applicable by country, of: (i) the ADA (Americans with Disabilities Act) (USA Only); (ii) Disability Discrimination Act 1992 (Australia Only); or (iii) other applicable local, regional, or national law or regulation. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview As a Clinical Support Specialist, you will be instrumental in driving sales revenues within your assigned territory by providing exceptional clinical support to customers. Your responsibilities will include engaging with customers to enhance sales, service, and overall customer experience. By leveraging your clinical expertise and product knowledge, you will support the development of sales opportunities and ensure effective utilization of our product portfolio. Collaboration with internal and external stakeholders, including Commercial Account Specialists (CAS), will be essential in achieving business objectives and maintaining customer satisfaction. Reporting to: Regional Business Manager Responsibilities The responsibilities will encompass, but will not be limited to: Business Area: Utilize the sales processes to create a territory plan. Ensure assigned sales revenues for that area are achieved. Ensure the price principles are applied in their accounts. Demonstrates knowledge of the contract and tendering process to benefit our commercial business. If a CAS is in the region: o Supports the CAS in meetings with allocated customers. o Provide relevant data to support opportunity targeting. o Applies business acumen in collaboration with CAS to ensure the commercial business plan objectives are achieved. o Identify key stake holders in collaboration with CAS to develop value-based opportunities. Customer: Territory Coverage Engage with customers to drive sales, service, and customer experience. Support our product and service delivery to customers to drive development of sales opportunities. Highly clinically and procedural aware, to support and drive sales opportunities by regally attending clinical cases. Provide excellent knowledge of the product portfolio and other possible devices related. Responsible for providing service to clinical customers defined. Case planning & support using cook products. Be present in the labs and help the staff achieve successful outcomes using cook products. Present and deliver product initiatives. Analysis opportunities within the account by case attendance, customer meetings and data. Provide technical product training to customers. Collects clinical, procedure and competitor data to support business analysis. Manages all assets to customers so they meet the company KPI's. Collaboration: Participates in commercial tasks to protect current business and creating new opportunities via this business route. Support the CAS by providing clinical data and feed back to allow for an improved commercial approach. Supports the CAS about the ordering process and key contacts within customer accounts. Supports the CAS with competitor data to enhance sales capabilities. Demonstrates a strong ability and use of communication skills with internal and external stakeholders. Has awareness and judgement to ask for support as required. Understands our company structure and the associated roles and responsibilities to support the collaborative approach. Understands each customer structure, roles, and responsibilities to aid the collaborative approach. Organizational: Meets or exceeds the administration requirements related to job role. Adheres to company policies, process, and procedures consistent with company timelines. Understand their role and how it fits into the Cook structure to ensure customer and business objectives are meet. Proves in their actions that they understand the importance of teamwork and how it aligns with the companies' policies and expectations. Working closely RBM to ensure goals are achieved and aligned with business plan. Participation at relevant local and international exhibitions, meetings and lectures forwarding relevant information to divisional team. Provide written reports and analysis to the Regional Business Manager as appropriate. Qualifications Qualifications / Requirements: Ability to meet frequently with customers and other decision makers. Ability to travel frequently throughout assigned territory. Proven track record of strong business acumen. Previous medical sales experience preferred. Product or Procedural knowledge an advantage. Good communication and inter-personal skills. Language Skills - good written and verbal command of English and other relevant languages. Excellent numeric skills. Good working knowledge of Microsoft Office. Proven problem-solving skills. Excellent organizational skills. High self-motivation. Prior sales experience is preferred. Availability and willingness to travel extensively on Company business. Average weekly travel is 2 to 3 overnights per week Current driving licence. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview The Post Market Specialist serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action and associated correspondence to applicable Regulatory bodies. Reporting to: Team Lead, Post Market Surveillance Find out more about Cook Medical here Responsibilities Assess complaints from Cook global customer support and delivery centres for adequate information to determine if event meets Regulatory Reporting requirements. Utilize appropriate complaint software systems for processing complaints to/from customer support and delivery centres and QE Investigation functions. Generate appropriate regulatory reports based on assessment. Liaise effectively with regulators on all issues with regard to regulatory reporting. Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner. Communicate with other Cook Companies globally as necessary for reporting. Generate responses to inquiries on AE reports from various global regulatory authorities. Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests. Input into the assessment of field action through the Health Risk Assessment process. Assist in coordination of Field Action administration activities between manufacturer and distribution centre. Close out of complaints as necessary. Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports. Maintains appropriate regulatory records to demonstrate compliance with applicable regulations. Maintain an excellent understanding of global medical device regulations. Knowledge of relevant ISO, EU, FDA medical device standards regulations is required. Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required. Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner. Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations. Performs additional duties as assigned. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Delegate for the Regulatory Communications Team Lead. Qualifications Third level Qualification in Science/Engineering desired. Experience in a regulated industry ( ideally minimum 1 years) in a similar role is required. Thorough knowledge of the EU & US medical device regulatory requirements. Knowledge of regulatory requirements in MDSAP countries. Desirable to have knowledge of requirements in other jurisdictions. Knowledge of medical device quality standards/practises or similar regulated industry. Good communication and inter-personal skills. Proven problem-solving skills. Good computer skills including knowledge of Microsoft Office. Proven organisational skills. High self-motivation. Willingness and availability to travel on company business. About Cook Limerick Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets. Quality Engineering in Limerick Our QE team in Limerick is made up of 4 different subgroups: quality engineering, supplier engineering, regulatory communications and complaint investigations. The quality engineering team are responsible for the CAPA, NCR, NC trending and field action assessments processes. They work cross functionality with operations, engineering, medical affairs and regulatory affairs during the design process and throughout the device lifecycle. They are heavily involved in supporting strategic objectives for the site including IT solutions and continuous improvement efforts. The supplier quality engineering team are responsible for the qualification, auditing, monitoring and assessment of all new and existing suppliers across this site. This ranges from quality impacting suppliers to non-quality impacting suppliers. The regulatory communications team are responsible for the regulatory assessment and submitting reports as required for all our device customer complaints. In addition, they are responsible for any field actions which are initiated associated with Cook Ireland manufactured devices as well as monitoring and implementing changes associated with regulatory intelligence and are a key input into the post market surveillance programme. The complaint investigations team are responsible for the root cause, evaluation, investigation, risk assessment and corrective action determination of all our device related customer complaints. They are responsible for the evaluation of any returned medical devices from the field in a biohazard laboratory. The complaint investigation team are also responsible for trending assessments and are a key input into the post market surveillance programme. Even though these teams are distinctively different in terms of roles and responsibilities, they are all intertwined as they are responsible for different aspects of the product lifecycle which ultimately all feed into one another. Our Quality Engineering team are central to holding Cook to the highest standards because everything we do has an impact on someone's life. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Overview Develop, communicate, and lead innovative medical education training programs to HCPs, including fellows and residents as applicable, for the assigned specialty(s) in the assigned geography that align the goals of Medical Education with the Division's specialty(s) priorities and overall company strategy and vision, to help our customers provide the best patient outcomes. Ensure programs delivered are efficient, effective, and compliant in meeting the needs of our customers and internal stakeholders and communicate those needs to Division Leadership. Collaborate with division teams, leaders, and stakeholders to establish internal teams to support and deliver medical education training programs and other associated responsibilities. Responsibilities - Coordinate and support implementation of medical education training programs for the assigned specialty(s), providing an overview of training course goals and learning objectives, course criteria and processes as part of a need's assessment for customer programs. - Develop and execute an annual medical education plan, including fellows and residents programming as applicable, for the assigned specialty(s) and geography, in partnership with Medical Education and Division leadership based on current and future product portfolio and procedural trends. - Responsible for annual budget projections and tracking of activities for assigned specialty(s) medical education training programs in the assigned geography, if applicable. - Approve and manage calendar of educational events to ensure structure and alignment with Medical Education and divisional goals for assigned or specialty(s) in the assigned geography, if applicable. - Identify HCP consultant partners that support education initiatives in collaboration with division stakeholders. Work closely and maintain regular communication with identified HCP consultants on all initiatives while maintaining compliance and legal standards. - Collaborate with relevant Marketing and Communication stakeholders and resources to develop marketing strategy for educational programs, including digital content and promotional strategies. - Monitor metrics and report effectiveness of Medical Education programs. Listen to feedback from customers and employees and take action to resolve issues and gaps quickly and effectively. - Demonstrate clear understanding of and adherence to compliance and legal standards and regulatory processes relative to technical and procedural education delivery and materials. - Meet deadlines and complete administrative tasks such as expenses, training, reporting, policy acknowledgements, etc. in a timely manner. - Understand and be accountable for conducting Cook business with integrity and in compliance with applicable standards including Cook policies. - Within scope of responsibility, ensure all quality, regulatory, compliance and product-specific requirements are met. Qualifications Required Experience: College degree in related field and/or equivalent relevant experience. Prior experience in medical education programs in the medical device industry. Preferred Qualification: Demonstrate strong leadership skills. Experience in a clinical or training environments Model the company standards that others are expected to follow. Demonstrate positive and constructive behaviors that drive team cooperation in achieving objectives. Demonstrate excellent communication, leadership, and presentations skills. Excels in a highly collaborative team setting. Demonstrate the ability to think strategically. Physical Requirements/Work Environment: Ability to travel as needed, up to 75%. Work under general office environmental conditions To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
