Strategic Regulatory Compliance Manager

3 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €95,000 - €118,000
Senior Regulatory Affairs Specialist

As a Senior Regulatory Affairs Specialist, you will play a key role in developing and implementing regulatory strategies to ensure compliance with global medical device regulations. Your primary focus will be on obtaining and maintaining regulatory approval for commercialization of medical devices in selected target markets.

Job Responsibilities:
  1. Maintain a deep understanding of global medical device regulations, primarily in accordance with specific FDA guidance & MDD 93/42/EEC.
  2. Develop global regulatory strategies for the company in collaboration with regulatory affairs management.
  3. Plan and prepare regulatory submissions with specific emphasis on US FDA, i.e., 510(k), HDE, IDE, and PMA submissions.
  4. Communicate directly with regulatory authorities to ensure product approvals are achieved in a timely manner.
  5. Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.
  6. Provide ongoing support to currently marketed products as necessary, including input on change notifications.
  7. Ensure a thorough understanding of the products assigned.
  8. Act as a designee for the RA management, if required.
  9. Lead the Design Review process in compliance with internal procedures, including EU and FDA requirements.
  10. Maintain the Design History files, including managing the filing, storage, and retrieval of Design Quality Records.
  11. Ensure all product quality standards and specifications are defined and achieved in line with company and regulatory requirements, including MDD 93/42 EEC and FDA requirements.
  12. Lead risk management process and preparation of risk management files, including Use and Design FMEAs as required.
  13. In conjunction with the design teams, identify product testing required and write design verification and validation plans, protocols, and reports, including advising on sample sizing; including but not limited to Ethylene Oxide sterilization, Biocompatibility, Stability, and Transportation testing.
  14. Prepare Standard Checklists for all applicable main harmonized standards.
Requirements:
  1. Minimum 5 years' experience in Regulatory Affairs, Design Assurance, or similar role in a medical device company.
  2. Primary and/or postgraduate degree BS, MS, or PhD (Mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field).
  3. Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
  4. Working knowledge of FDA requirements, including Quality System Regulation (21 CFR 820), the Medical Device Directive (93/42/EEC), and applicable harmonized standards, and the ability to apply them in practice.
  5. Previous experience with submissions to US FDA is a distinct advantage.

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