Regulatory Affairs Specialist

3 weeks ago


Bristol, Bristol, United Kingdom Yolk Recruitment Ltd Full time
Regulatory Affairs Specialist - Medical Devices

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

The successful 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 with 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 ideal 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.
  • EU MDR 2017/747 CE compliance and marking.
  • EC 60601 family compliance ETL/UL marking.
  • ISO 13485 QMS.
  • ISO 14971 Risk analysis.
  • Patents and Trademarks.

Yolk Recruitment Ltd is a leading recruitment agency specializing in the medical device industry. We are committed to finding the best talent for our clients and providing exceptional service to our candidates.



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