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Regulatory Affairs Specialist
1 week ago
Vectura Ireland Limited 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 also contribute to global regulatory strategy and drive the approval process for all medical device submissions.
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.
The ideal candidate will have extensive experience in regulatory affairs for medical devices, 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.
About Vectura Group plcWe are an international community of scientists, clinicians, engineers, regulatory specialists, quality managers, and more. Working closely together in an open and inclusive way, we push ourselves and each other to develop innovative, world-leading drug delivery solutions that improve people's lives.
