About Aerogen: Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and ten-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care. Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter. What is the role? Aerogen, a global leader in aerosol drug delivery, reporting significant YoY revenue growth, is seeking a Business Partner to Aerogen's Commercial Leaders. The role involves analysing actual performance, guiding the team on meeting quarterly forecasting and annual budgeting requirements. Based out of Galway, Ireland. What are the key responsibilities? Business partner to Aerogen's Commercial Leaders, analysing actual performance and guiding quarterly forecasting and annual budgeting. Direct and lead on deal pricing and commercial contracts & projects through insightful modelling and scenarios. Be technically astute to influence senior management to drive business performance and to make high‑quality financial decisions. Be a key player in the finance team, developing multi‑year strategic plans and annual budgets for volume, revenue, margins and operating expenses, and converting this data into insightful metrics, trends and comparisons for senior leaders and board members. Continuously seek and implement process improvements to streamline activities and ensure continued value add enablement to budget holders. Coaching junior finance colleagues and non‑finance colleagues to share knowledge and strengthen financial acumen and management. Support the Director of FP&A and the CFO on modelling for strategic company critical projects. Be alert to business needs, proactively providing direction and financial insights to support decision‑making. What education and experience are required? Professional accountancy qualification. Relevant experience with a commercial company requiring quarterly reporting. Minimum of 3+ years of combined finance, FP&A or accounting experience, including people leadership. Experience partnering with senior stakeholders, influencing decisions with market intelligence and data. What key skills will make you great at the role? Evidence of a trusted business partner: possess technical expertise and good judgement to provide budget holders with an objective, independent point of view to drive performance. Proven track record in achieving results in a proactive/business partnership environment. Ability to work independently while collaborating effectively within a global team. Exceptional organisation and multitasking skills – ability to prioritise. Strong work ethic and collaborative mindset. What is it like to work in Aerogen? Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non‑financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer: Excellent medical care. Bonus & pension. ‘Aerogen Connect’ – our employee‑led programme which supports our global teams to unite and have fun. We pledge 1% of profits and time to charities and organisations. Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com . Please include your name and preferred method of contact. Job Title Finance Business Partner – MEA/OEM Product approvals and set‑ups may vary by country. Always refer to the user instructions supplied with the product for full set‑up instructions, warnings, cautions and contraindications. #J-18808-Ljbffr
A leading global medical technology company based in Galway is seeking a Senior RA Specialist II to lead regulatory strategy. The role involves developing global strategies, conducting due diligence for acquisitions, and managing CE mark submissions. Candidates should have an Honours degree in Quality or Regulatory Affairs, along with 6-9 years of experience in Regulatory Affairs. The position provides an excellent opportunity to contribute to innovative healthcare solutions in a dynamic environment. #J-18808-Ljbffr
A leading healthcare company in Galway is seeking a Finance Business Partner to support its Commercial Leaders. This role involves analyzing financial performance, budgeting, and guiding senior management on financial decisions. The ideal candidate will have a professional accountancy qualification and over 3 years of relevant finance experience. The position offers a collaborative environment with opportunities for growth and a generous benefits package including medical care and bonuses. #J-18808-Ljbffr
Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and ten-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care. Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter. What is the role? A regulatory strategy involves bringing new products to market and encompasses the product life cycle, which supports the growth and sustainability of the organisation's commercial footprint. The importance of defining and executing an appropriate regulatory strategy cannot be underestimated in terms of its value to the organisation. The Senior RA Specialist II will work as part of Aerogen's Global Strategic Regulatory Affairs team and will be involved in establishing and executing regulatory strategies for the organisation. What are the key responsibilities? Define Global Regulatory Strategies: Develop and implement comprehensive global regulatory strategies for products throughout the product development lifecycle, ensuring alignment with business objectives and compliance requirements. Execution of Due Diligence for Acquisitions: Conduct thorough regulatory due diligence activities for potential acquisitions, assessing compliance risks and integration opportunities. Regulatory Affairs (RA) Stakeholder Communication: Provide timely and accurate RA inputs to functional stakeholders, ensuring all relevant parties are informed of regulatory changes and challenges affecting specific countries and regions involved in strategic initiatives. Provide support to Business stakeholders: Collaborate with Research & Development, Commercial, Legal, Medical Affairs, Quality, Operations, and Manufacturing teams, offering regulatory guidance and support throughout all stage gates of the new product development process. Leadership in MDR 2017/745 Program: Lead and actively participate in the Medical Device Regulation (MDR) 2017/745 program from a Regulatory Affairs perspective, ensuring ongoing compliance and successful program execution. CE Mark Submissions and Notified Body Management: Manage submissions for CE marking, significant change notifications, and interactions with Notified Bodies, ensuring timely and accurate documentation and communication. Local Actor Administrator (LAA) in EUDAMED: Act as the Local Actor Administrator for Aerogen in EUDAMED, overseeing and maintaining all relevant details and ensuring regulatory compliance within the database. Preparation and Management of 510(k) Filings: Assist in preparing 510(k) regulatory filings and manage subsequent correspondence with the FDA, supporting submission processes and regulatory responses. Regulatory Assessments and QMS Changes: Manage and complete regulatory assessments related to Aerogen products and Quality Management System changes, conducting subsequent registration activities with regulatory agencies based on evaluation outcomes Audit Preparation and Follow-Up: Participate in the preparation and follow-up activities for audits conducted by Notified Bodies and Regulatory Agencies, ensuring audit readiness and compliance. RA ERP Activities: When required, complete Regulatory Affairs Enterprise Resource Planning (ERP) activities to support product release and ensure regulatory compliance is maintained. Continuous Improvement Initiatives: Identify and contribute to continuous improvement initiatives within the regulatory department, enhancing processes and departmental efficiency. Global Regulation Monitoring and Implementation: Conduct ongoing review and monitoring of global regulations, disseminating updates and implementing changes into product files and procedures as necessary. Non-Conformance and CAPA Involvement: Participate in the completion of Non-Conformances and Corrective and Preventive Action (CAPA) activities to resolve regulatory issues and ensure robust compliance. Mentoring and Training: Provide mentoring and training support for associates and direct reports as required, fostering professional development and regulatory knowledge within the team. The role holder must remain responsive to modifications in duties as requested by the Senior Manager of Global Strategic Regulatory Affairs. What key skills will make you great at the role? The successful candidate will demonstrate a comprehensive set of skills and competencies essential for excelling in a highly regulated, innovation-driven environment. These capabilities are integral to maintaining Aerogen’s reputation for excellence, ensuring compliance, and supporting the organisation’s strategic objectives. Collaboration and Stakeholder Engagement: Stakeholder Collaboration: Proven ability to work effectively with cross-functional teams and external partners. Skilled at engaging with stakeholders to facilitate regulatory compliance and business objectives. Teamwork: Strong interpersonal skills with the ability to contribute positively to team dynamics and support collective success. Self-Management and Initiative: Initiative and Independence: Demonstrates a high degree of self-motivation, managing tasks proactively in a timely manner and independently while maintaining alignment with organisational goals. Business Acumen: Risk Identification and Problem-Solving: Sound judgement in identifying potential risks and developing effective mitigation strategies. Capable of analytical thinking to resolve complex regulatory and business challenges. Commercial Growth Focus: Awareness of commercial drivers and the ability to align regulatory strategies with broader business objectives to support sustainable growth. Demonstrate a high degree of flexibility and adaptability to manage a diverse range of regulatory tasks. Technical Writing and Communication: Documentation Skills: Exceptional technical writing skills, with the ability to produce clear, concise, and accurate regulatory and quality documentation. Communication: Effective communicator, adept at conveying complex information to diverse audiences in a structured and accessible manner. Continuous Improvement & Detail Oriented: Methodical Review: Strong aptitude for conducting systematic reviews of processes and documentation to ensure ongoing compliance and operational excellence. A high level of accuracy and meticulousness is required to ensure compliance and quality in all regulatory submissions and processes. Planning and Coordination: Proven skills in planning and coordinating projects and tasks, ensuring deadlines are met and regulatory requirements are achieved efficiently. Alignment with Organisational Culture: Values and Behaviours: Commitment to upholding Aerogen’s organisational values, fostering a culture of ambition, teamwork, integrity and innovation. Demonstrated alignment with company behaviours and ethical standards. What education and experience are required? Candidates must possess a minimum of an Honours degree in Quality, Regulatory Affairs, or a closely related discipline within Science or Engineering. Additionally, applicants should demonstrate between six to nine years of substantial hands-on experience in Regulatory Affairs. Proven track record in regulatory affairs, quality management, or related disciplines within the medical device sector. Possession of relevant academic qualifications supporting a foundation in regulatory science and compliance In-depth knowledge of relevant medical device regulations, including ISO 13485, FDA Quality System Management Regulation (QSMR), MDSAP, and a thorough understanding of MDR 2017/745 (as amended). Demonstrated capability in interpreting, applying, and advising on regulatory requirements. Prior experience working with usability and electrical medical devices will be considered a significant advantage for this position. Standards Knowledge: Expert understanding of international quality standards, specifically ISO 13485, Regulation knowledge: Expert understanding of international regulations, specifically FDA QSMR, MDSAP, and MDR 2017/745 (as amended). What is it like to work at Aerogen? Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer: Excellent medical care. ‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun. We pledge 1% of profits and time to charities and organisations. Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact. #J-18808-Ljbffr
A leading medical technology company is seeking an Associate Medical Science Liaison to engage with key opinion leaders and healthcare professionals in the APAC region. The role involves supporting medical strategy, evidence generation, and participation in clinical trials. Candidates should have a background in Medical Affairs and be skilled in scientific communication. This position offers opportunities for professional growth and may require 60–80% travel. Join a team dedicated to improving patient outcomes and pioneering innovative solutions. #J-18808-Ljbffr
Overview Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and ten-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care. Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter. What is the role? As an Associate Medical Science Liaison (MSL), you will ensure the safe and effective use of Aerogen’s devices by engaging with key opinion leaders (KOLs), healthcare professionals, regulators, and partners across the APAC region. You will help shape Aerogen’s medical strategy, support evidence generation, and contribute to educational and scientific exchange activities. Responsibilities Build strong relationships with KOLs and external stakeholders. Plan and execute the local medical strategy for your territory. Present and communicate Aerogen’s clinical data and scientific evidence. Support investigator-initiated clinical trials and evidence generation. Represent Aerogen at national and international conferences. Field-based role: 60–80% travel (regionally across APAC). Mix of remote, field and office work. Education and experience Previous experience in Medical Affairs is desirable. Knowledge of respiratory diseases and the medical device or pharmaceutical industry preferred. Key skills Skilled in scientific communication, relationship-building, and collaboration. Experience with clinical documentation and publications. Fluent in English (written and spoken). Familiar with Good Clinical Practice (GCP). What is it like to work in Aerogen? Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer: Opportunities for development and professional growth. "Aerogen Connect" – our employee-led program that helps our global teams unite and have fun. We donate 1% of profits and time to charities and organizations. Visit our careers website for more information about life at Aerogen. Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. If you have difficulty using our application process, please contact us via email at careers@aerogen.com. Please provide your name and preferred contact method. #J-18808-Ljbffr
About Aerogen: Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and ten-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care. Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter. What is the role? The Medical Science Liaison (MSL) is the field-based scientific expert on their assigned therapy area, disease area, clinical practice and competitor landscape. You will provide non-promotional medical support externally to ensure the safe and effective use of Aerogen’s devices. This role is mainly field-based and involves significant (up to 60%) national and international travel and reports directly to the Head of Medical Affairs, Americas. Direct territory responsibility is in the Southeast territory. What are the key responsibilities? Interaction with Key Opinion Leaders – (KOLs) Provide fair and balanced information on the benefits and risks of products, therapeutic options and disease state. Identification and development of KOL, fostering professional relationships Obtain feedback and advice about company products or pipeline through peer‑to‑peer interactions and advisory boards and communicate relevant information back to internal stakeholders in a timely manner. Facilitate the initiation, development, and ongoing maintenance of centres of excellence, and programmes to develop speakers from these centres Successfully connect opinion leaders globally or locally to serve as advisors, investigators, expert guest speakers, business development partners and to help facilitate the adoption of Aerogen’s products into national/international acute care guidelines. Regularly collect and interpret medical insights and feedback gathered from scientific exchange with opinion leaders and communicate relevant information to internal stakeholders in order to define, update, and support medical strategies. Support Research Endeavours Act as a conduit for unsolicited, investigator‑initiated research proposals by facilitation proposal, advise on the mechanics of the application guidance, and act as a conduit to senior management, for the publication of studies Managing Aerogen’s clinical trials in the specified territories Work closely with the commercial function to provide marketing and sales with the clinical and scientific data and background support that they need to grow Aerogen’s market share Attend scientific meetings and symposia: • Provide timely synopsis of information presented to internal colleagues • Gather competitive intelligence and report back to Aerogen Provide Scientific Information and Education Support Discuss disease state or product information through peer‑to‑peer interactions Answer questions on appropriate off‑label information in response to unsolicited questions Recommend, recruit and train participants for speaker bureau providing support with informational needs of speaker and faculty Conduct medical educational training for internal partners Provide scientific support to commercial and Medical Affairs partners, including training, medical writing, education and other scientific projects Collaborate, participate and contribute to cross‑functional teams and initiatives with internal departments (Clinical, Marketing, Sales, Training) What education and experience are required? Life Sciences degree, PhD, MD or Pharm D with a Medical / Clinical Focus. Clinical experience with aerosol therapy, critical care, and/or respiratory care What key skills will make you great at the role? Presentations at scientific meetings and to HCPs Recruitment and negotiation of clinical trial sites and KOL experts providing consultancy for Aerogen Good computer skills. Experienced with Microsoft Office applications for generating office documents, spreadsheets, project plans, etc. International and domestic travel will be required for this position and will equate to up to 60% of the individual's time. Persons applying for this position would need to reside within [REGION] in support of area customer initiatives. Changing priorities; long hours occasionally required to complete projects or at congresses/meetings. Handle multiple projects with tight deadlines. Typical office environments, with work also performed in Science labs and hospital clinical environment. What is it like to work in Aerogen? Competitive bonus plan. Above market life insurance. Opportunities for development and professional growth. "Aerogen Connect" – our employee‑led program that helps our global teams unite and have fun. We donate 1% of profits and time to charities and organizations. Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. If you have difficulty using our application process, please contact us via email at careers@aerogen.com. Please provide your name and preferred contact method. Job Title Medical Science Liaison (Southeast) Product approvals and set ups may vary by country. Always refer to the user instructions supplied with the product for full set up instructions, warnings, cautions and contraindications. #J-18808-Ljbffr
A leading medical technology company in Galway is seeking a Medical Science Liaison to provide non-promotional medical support and develop relationships with Key Opinion Leaders (KOLs). The role requires significant travel (up to 60%) and involves managing clinical trials and supporting marketing efforts with scientific insights. Ideal candidates will possess a Life Sciences degree and experience in aerosol therapy, critical care, or respiratory care. Competitive compensation and opportunities for professional development are offered. #J-18808-Ljbffr
About Aerogen Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and ten‑time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries. Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care. Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter . What is the role? Medical Science Liaison (MSL) is the field-based scientific expert on the assigned therapy area, disease area, clinical practice and competitor landscape. The MSL provides non‑promotional medical support externally to ensure the safe and effective use of Aerogen’s devices. This role is mainly field‑based and involves significant (up to 60%) national and international travel and reports directly to the Senior Global Medical Affairs Manager. Direct territory responsibility is the South Central territory. Key Responsibilities Interaction with Key Opinion Leaders (KOLs) Provide fair and balanced information on the benefits and risks of products, therapeutic options and disease state. Identify and develop KOLs, fostering professional relationships. Obtain feedback and advice about company products or pipeline through peer‑to‑peer interactions and advisory boards and communicate relevant information back to internal stakeholders in a timely manner. Facilitate the initiation, development, and ongoing maintenance of centres of excellence, and programmes to develop speakers from these centres. Successfully connect opinion leaders globally or locally to serve as advisors, investigators, expert guest speakers, business development partners and to help facilitate the adoption of Aerogen’s products into national/international acute care guidelines. Regularly collect and interpret medical insights and feedback gathered from scientific exchange with opinion leaders and communicate relevant information to internal stakeholders in order to define, update, and support medical strategies. Support Research Endeavours Act as a conduit for unsolicited, investigator‑initiated research proposals by facilitating proposal, advising on the mechanics of the application guidance, and acting as a conduit to senior management for the publication of studies. Manage Aerogen’s clinical trials in the specified territories. Work closely with the commercial function to provide marketing and sales with the clinical and scientific data and background support that they need to grow Aerogen’s market share. Attend scientific meetings and symposia Provide timely synopsis of information presented to internal colleagues. Gather competitive intelligence and report back to Aerogen. Provide Scientific Information and Education Support Discuss disease state or product information through peer‑to‑peer interactions. Answer questions on appropriate off‑label information in response to unsolicited questions. Recommend, recruit and train participants for speaker bureau, providing support with informational needs of speaker and faculty. Conduct medical educational training for internal partners. Provide scientific support to commercial and Medical Affairs partners, including training, medical writing, education and other scientific projects. Collaborate, participate and contribute to cross‑functional teams and initiatives with internal departments (Clinical, Marketing, Sales, Training). Education and Experience Life Sciences degree, PhD, MD or Pharm D with a Medical/Clinical focus. Clinical experience with aerosol therapy, critical care, and/or respiratory care. Key Skills Presentations at scientific meetings and to HCPs. Recruitment and negotiation of clinical trial sites and KOL experts providing consultancy for Aerogen. Good computer skills. Experienced with Microsoft Office applications for generating documents, spreadsheets, project plans, etc. International and domestic travel will be required for this position and will equate to up to 60% of the individual's time. Persons applying for this position would need to reside within the region in support of area customer initiatives. Handling changing priorities; willingness to work long hours occasionally to complete projects or at congresses/meetings. Handle multiple projects with tight deadlines. Typical office environments, with work also performed in science labs and hospital clinical environment. What is it like to work in Aerogen? Our purpose is to transform patient lives and our ethos is to #discoverbetter . This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non‑financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer: Benefits Competitive bonus plan. Above‑market life insurance. Opportunities for development and professional growth. "Aerogen Connect" – our employee‑led program that helps our global teams unite and have fun. We donate 1% of profits and time to charities and organizations. Visit our careers website for more information about life at Aerogen. Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. If you have difficulty using our application process, please contact us via email at careers@aerogen.com. Please provide your name and preferred contact method. Job Title Medical Science Liaison (South Central) #J-18808-Ljbffr
A leading medical device company in Galway is looking for a Medical Science Liaison (South Central) to act as the scientific expert in aerosol therapy. This role involves interacting with Key Opinion Leaders, managing clinical trials, and providing education support, requiring significant travel. Candidates should possess a Life Sciences degree and relevant clinical experience, as well as strong presentation and communication skills. The ideal applicant is organized, capable of handling multiple priorities and is willing to work in a dynamic team environment. #J-18808-Ljbffr
