Regulatory Affairs Specialist

4 weeks ago


Penicuik, Midlothian, United Kingdom fish4.co - Jobboard Full time

At fish4.co - Jobboard, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for building regulatory strategy, determining applicable regulatory requirements, and proposing solutions to comply with regulatory requirements. This role will also involve managing product license registration with the appropriate regulatory authorities worldwide.

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. Key responsibilities will include:

  1. Developing and implementing regulatory compliance processes, including regulatory evaluation of changes and non-conformances, post-market surveillance, vigilance, and associated reporting.
  2. Staying up-to-date with regulatory and standard watch, and ensuring compliance with all relevant regulations.

This is an exciting opportunity for a motivated and detail-oriented individual to join our team and contribute to the success of our medical device company.



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