Regulatory Affairs Specialist

4 weeks ago

Penicuik, Midlothian, United Kingdom Stem Recruitment Full time

Stem Recruitment is seeking a highly skilled Regulatory Affairs Specialist to join a medical device company based near Edinburgh. The successful candidate will be responsible for:

Key Responsibilities:
  • Building Regulatory Strategy: Develop and implement regulatory strategies to ensure compliance with applicable regulations and standards.
  • Determining Regulatory Requirements: Identify and assess regulatory requirements for medical devices, including those related to product registration, labeling, and advertising.
  • Proposing Solutions: Develop and propose solutions to comply with regulatory requirements, including the development of regulatory compliance processes and procedures.
  • Managing Product Registration: Manage the registration of medical devices with regulatory authorities worldwide, including the preparation and submission of regulatory documents.
  • Maintaining Regulatory Compliance: Ensure ongoing compliance with regulatory requirements, including the monitoring of regulatory changes and the implementation of corrective actions as needed.

The ideal candidate will have a relevant degree and/or relevant work experience in a regulatory affairs environment, as well as experience in the medical device / IVD / biotech industry.

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