Role Title: Senior Regulatory Affairs Specialist II (Strategic Regulatory)
We are currently recruiting a Senior Regulatory Affairs Specialist II for a Medical Device Manufacturer in Co. Galway. 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 the Global Strategic Regulatory Affairs team and will be involved in establishing and executing regulatory strategies for the organisation.
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 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 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 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 6-9 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 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 the company's reputation for excellence, ensuring compliance, and supporting the organisation’s strategic objectives.
Collaboration and Stakeholder Engagement: Proved 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 the company's organisational values, fostering a culture of ambition, teamwork, integrity and innovation. Demonstrated alignment with company behaviours and ethical standards.
Whats on offer?
Competitive salary.
Excellent medical care.
Bonus & Pension.
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