Regulatory Affairs Manager for Medical Devices
2 weeks ago
**Job Overview**
Vectura Group plc is seeking a highly experienced 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.
The successful candidate will contribute to global regulatory strategy and drive the approval process for all medical device submissions, ensuring that Vectura's corporate goals are achieved. Key responsibilities include:
- Ensuring full compliance with the Medical Device Regulations (MDR) in your capacity as PRRC for the European Authorized Representative.
- Leading communications and interactions with Competent Authorities regarding Vectura's duties as Authorized Representative.
In broader Regulatory Affairs responsibilities, the successful candidate will:
- 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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Tullamore, Uíbh Fhailí, Ireland beBee Careers Full timeSenior Manager Regulatory Affairs for Medical Devices and Person ResponsibleThis role plays a key part in ensuring compliance with European medical device regulations as the Authorized Representative. The successful candidate will also contribute to global regulatory strategy and drive the approval process for all medical device submissions.Key...
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