Senior Regulatory Affairs Associate

3 days ago

United Kingdom Cure Talent Full time

Cure Talent are delighted to be working with a well-established Medical Device company that supply and distribute innovative Medical Devices. Due to their continued growth and success, we have an exciting opportunity for a Senior Regulatory Affairs Associate to join them in West Yorkshire.

As the new Senior Regulatory Affairs Associate, you will be working closely with the Regulatory Affairs Manager to support Regulatory Compliance across the business, creating, reviewing and updating Technical Files, PMS and Auditing.

To be successful in this role, you will be an experienced Regulatory Affairs professional with a proven background in the Medical Device sector. Technical knowledge and experience should encompass Technical File management, PMS activities and MDD/MDR compliance.

Key Role Responsibilities

  • MDD & MDR Compliance
  • Technical File creation, review and updating
  • Post Market Surveillance
  • Regulatory Compliance in line with ISO 13485
  • Internal Auditing

Required Skills, Experience & Education

  • Proven experience in the Medical Device Sector within a RA role
  • Experience of Technical File management and/or creation
  • Post Marketing Surveillance experience
  • Proven experience with MDD, MDR and ISO 13485

If this sounds like you and you’re looking to join an established, yet growing company at the forefront of creating better patient outcomes, get in touch with Kris Holmes at Cure Talent today

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