Regulatory Affairs Manager

Our client, a global Medical Device manufacturing company specializing in Fem Tech, is looking for a Regulatory Affairs Manager to join an exciting team reporting to the Director of Regulatory Affairs. The company produces equipment, consumable medical devices, and general laboratory equipment. A cross-functional role, the chosen candidate will work with internal and international teams/departments.

The company will offer hybrid or remote working for those further away if needed.

Summary:

The Regulatory Affairs Manager is responsible for:

1. Regulatory strategy to attain and maintain EU, US, and UK device certifications and market clearance.
2. Regulatory assessment of changes to devices, processes, supply chain, and regulations, and resultant notification and re-registration activities.
3. Proactively monitoring changes in EU and UK medical device regulations and providing training to global Regulatory Affairs teams, commercial, distribution, and service teams.
4. UKCA mark compliance and MHRA registration and listing.

Skills:

1. Management, support, and development of RA team members responsible for creation and maintenance of Technical Documentation Files and Device History Files.
2. Managing RA projects and defining strategy for new product development, maintenance of legacy device portfolio, acquisitions, etc.
3. Proactively monitoring changes in regulations and providing training to Regulatory Affairs teams, commercial, distribution, and service teams.
4. Managing the creation and maintenance of Technical Documentation Files.
5. Ensuring effective project management for product certification, registration, and re-registration.
6. RA strategic planning and assessments.
7. Regulatory representative and advisor for new product development at the concept phase.
8. Developing business relationships with key stakeholders (internal/external).
9. Achieving measurable results in all certifications and ongoing submissions.
10. Participating in training and attending conferences and meetings.
11. Providing regulatory support during surveillance audits as necessary to maintain international licenses, registrations, and certification.
12. Leading Regulatory support for closure of non-conformances raised at internal or external audits.
13. Regulatory Lead for QMS documentation, change control, and design and process deviation management.
14. Regulatory Lead point contact for global vigilance, FSCAs, and recalls.

Qualifications:

1. Knowledge of medical device requirements primarily for US and EU markets.
2. Ability to read and interpret medical device regulations and requirements.
3. Ideally a degree in Life Science, Engineering, Compliance, etc. OR equivalent practical expertise.

Job Info

Job Title: Regulatory Affairs Manager

Company: CV-Library

Location:

Posted:

Closes: Jan 4th 2025

Sector: Manufacturing & Surveying

Contract: Permanent

Hours: Full Time

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