Regulatory Affairs Specialist

1 month ago


Bristol, Bristol, United Kingdom Yolk Recruitment Full time

Regulatory Affairs Specialist (Contract)

Yolk Recruitment is partnering with a growing medical device manufacturer to fill a new opportunity for a Regulatory contractor. You will support a range of regulatory activities, including:

  • Supporting worldwide regulatory submissions.
  • Reviewing and managing standards databases and advising on implementing changes to technical files as required.
  • Supporting the creation and implementation of compliant regulatory procedures.

You will need:

  1. Previous experience in Medical Devices Regulatory Affairs and knowledge of UK MDR 2022 UKCA compliance and marking.
  2. EU MDD 93/42/EEC CE compliance and marking.
  3. UKCA compliance and marking.
  4. EU MDR 2017/745 CE compliance and marking.
  5. EC 60601 family compliance ETL/UL marking.
  6. ISO 14971 risk analysis.


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