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About the Role
We are seeking an experienced Regulatory Affairs professional to lead our medical devices and combination products clinical trial regulatory strategy. In this pivotal role, you will provide expert guidance on regulatory pathways for clinical investigations and serve as the key regulatory representative for our global project teams.
The role can be office or home based in various European locations.
Key Responsibilities
1. Develop comprehensive regulatory strategies and dossiers for clinical investigations of medical devices and combination products.
2. Act as the regulatory lead during audits and inspections related to device clinical investigations.
3. Represent the regulatory affairs function in global project teams and governance meetings.
4. Lead regulatory interactions with health authorities, including preparation of documentation and coordination of meetings.
5. Manage regulatory activities throughout the device clinical development lifecycle.
6. Maintain global regulatory databases (e.g., Veeva) with accurate and current information.
7. Collaborate with CMC and QA departments on device change control processes and global submission requirements.
8. Support internal and external audits related to medical device quality systems.
9. Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions.
10. Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function.
Skills and Experience required for the role:
11. University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline.
12. Minimum 5+ years of experience in regulatory affairs for medical devices, specifically in clinical investigations of medical devices and/or drug-device combination products.
13. In-depth knowledge of global medical device regulations (e.g., EU MDR, FDA regulations).
14. Proven experience in global regulatory strategy and dossier preparation for EU (e.g., CTAs, clinical investigations) and US (e.g., INDs, IDEs, 510(k), PMA) submissions.
15. Familiarity with regulatory frameworks including EU-MDR, ICH, MDSAP, ISO 13485, ISO 14155, GCP, and cGMP.
16. Excellence in regulatory documentation processes and submission management
17. Experience leading regulatory interactions with health authorities and key stakeholders.
18. Strong track record representing companies during regulatory audits and inspections.
19. Fluent in English, written and spoken.
20. Experience also in vitro diagnostic devices would be a plus.
21. Proficiency with regulatory systems including Veeva and TrackWise would be a plus.