Regulatory Affairs Expert for Medical Devices
4 weeks ago
Vectura is seeking a Senior Manager in Regulatory Affairs for Medical Devices who will also assume the critical role of Person Responsible for Regulatory Compliance (PRRC). This position plays a key role in ensuring compliance with European medical device regulations as Vectura's Authorized Representative.
Key Responsibilities:
- 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.
Ensure accurate maintenance and archiving of device registrations and technical documentation to meet legal and regulatory standards.
Support the creation of regulatory documentation, including risk management, design history files (DHF), instructions for use (IFU), and labeling.
Advise on regulatory strategy for clinical trials and commercial activities, including compliance with local legislation and language requirements.
Analyze and interpret new or updated regulatory standards and assess their impact on Vectura's processes.
This is an exciting opportunity for a senior professional with extensive experience in regulatory affairs for medical devices, eager to contribute to innovative healthcare solutions at Vectura.
Requirements:
- Proven experience in regulatory affairs for medical devices.
- In-depth understanding of the Medical Device Directive and Medical Device Regulations.
- 10 years' experience in Regulatory Affairs is a legal requirement to be an Authorized Representative.
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