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EU Authorized Representative

1 week ago

Portlaoise, Laois, Ireland Vectura Group plc Full time

Senior Manager in Regulatory Affairs for Medical Devices - EU Authorized Representative

Vectura Ireland Limited is seeking a senior professional with extensive experience in regulatory affairs for medical devices to join our team 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.

Main Responsibilities
  • Ensure full compliance with the Medical Device Regulations (MDR) in your capacity as PRRC for the European Authorized Representative.
  • Contribute to global regulatory strategy and ensure the successful approval of medical devices worldwide.

The ideal candidate will have a proven track record 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 plc

We 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.