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Regulatory Affairs Specialist

4 weeks ago

Bristol, Bristol, United Kingdom Yolk Recruitment Careers Full time

Regulatory Affairs Specialist

Yolk Recruitment Careers is partnering with a growing medical device manufacturer to find a Regulatory Affairs Specialist for a new contract opportunity.

The ideal candidate will support a range of regulatory activities, including:

  • Creation and updating of technical files, reports, and procedures.
  • Compiling vigilance PMS and PSUR reports.
  • Supporting worldwide regulatory submissions.
  • Assisting with Competent Authority registrations, including the MHRA and ECREP.
  • Liaising with all departments to obtain required documentation for technical file and registration updates.
  • Creating Declarations of Conformity.
  • Reviewing and managing standards database and advising/implementing changes to the technical files as required.
  • Supporting the management of Patents and Trademarks.
  • Supporting the creation and implementation of compliant Regulatory procedures.

The successful candidate will have previous experience in Medical Devices Regulatory Affairs and knowledge of UK MDR 2022 UKCA compliance and marking, EU MDD 93/42/EEC CE compliance and marking, UKCA compliance and marking, and EU MDR 2017/745 CE compliance and marking.