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Regulatory Affairs Specialist

1 month ago

Bristol, Bristol, United Kingdom Yolk Recruitment Ltd Full time

Role Overview


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


This part-time role requires 2-3 days of work per week and is initially 4 months long, with possible extensions.


As a Regulatory Affairs Specialist, you will support a range of regulatory activities, including worldwide submissions, reviewing and managing standards databases, and creating and implementing compliant procedures.


Key Responsibilities



  • Supporting with world-wide regulatory submissions
  • Reviewing and managing standards database and advising/implementing changes to the technical files as required
  • Supporting the creation and implementation of compliant Regulatory procedures

Requirements



  • 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 2017/745 CE compliance and marking
  • EC 60601 family compliance ETL/UL marking
  • ISO 14971 Risk analysis

About the Company


Our client is a growing medical device manufacturer seeking a skilled Regulatory Affairs Specialist to join their team.


They offer a remote work environment with infrequent site visits and a part-time schedule.