EU Medical Device Regulation Specialist Senior Manager
5 days ago
Principal 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.
- Lead communications and interactions with Competent Authorities regarding Vectura's duties as 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.
- Support the submission process for drug-device combination products in partnership with internal teams or external partners.
- Analyze and interpret new or updated regulatory standards and assess their impact on Vectura's processes.
- Contribute to the Vectura Regulatory Newsletter, providing updates on key regulatory topics.
- Assist in planning, executing, and documenting verification and validation activities.
- Serve as deputy to the Associate Director, EUAR & Importer, when needed.
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.
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