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Senior Medical Device Compliance Manager
2 weeks ago
This exciting opportunity has arisen for a senior professional with extensive experience in regulatory affairs for medical devices to join Vectura Ireland Limited as a Senior Manager in Regulatory Affairs for Medical Devices. The successful candidate will assume the critical role of Person Responsible for Regulatory Compliance (PRRC) and contribute to global regulatory strategy.
Accountabilities- As Person Responsible for Regulatory Compliance (PRRC): Ensure full compliance with the Medical Device Regulations (MDR) in your capacity as PRRC for the European Authorized Representative.
- In broader Regulatory Affairs responsibilities:
- Contribute to global regulatory strategy and ensure the successful approval of medical devices worldwide.
- Prepare final regulatory documentation and communicate with regulatory authorities and notified bodies.
- Lead or support key projects, including EUDAMED implementation, Quality System Management Reviews (QSMR), UKCA, and development of new devices.
The ideal candidate will have a deep understanding of the Medical Device Directive and Medical Device Regulations, strong communication and leadership skills, and the ability to collaborate across departments. They will also be an SME in MDR and have 10 years' experience in Regulatory Affairs, which is a legal requirement to be an Authorized Representative.
