Regulatory Affairs Specialist

3 weeks ago


Keighley, Bradford, United Kingdom Cure Talent Full time
Job Overview

Cure Talent is excited to present an opportunity for a Senior Regulatory Affairs Associate to join a well-established Medical Device company in West Yorkshire. The ideal candidate will possess strong technical knowledge and experience in the Medical Device sector.

This role involves working closely with the Regulatory Affairs Manager to ensure regulatory compliance across the business, including creating, reviewing, and updating Technical Files, PMS, and auditing.

The successful candidate will have a proven background in Regulatory Affairs, encompassing Technical File management, PMS activities, and MDD/MDR compliance.

  • Maintaining MDD & MDR compliance
  • Creation, review, and updating of Technical Files
  • Post-Market Surveillance
  • Ensuring Regulatory Compliance in line with ISO 13485
  • Conducting internal audits
Key Responsibilities

The key responsibilities include:

  • Managing Technical Files and ensuring MDD/MDR compliance
  • Coordinating Post-Market Surveillance activities
  • Developing and implementing processes for Regulatory Compliance
  • Collaborating with cross-functional teams for effective implementation
Requirements

To be successful in this role, the ideal candidate should possess the following qualifications:

  • Proven experience in the Medical Device Sector within a RA role
  • Technical expertise in creating, reviewing, and updating Technical Files
  • Experience in managing PMS activities
  • Strong understanding of MDD, MDR, and ISO 13485 regulations
Benefits

The company offers a competitive salary range of £45,000 - £55,000 per annum, depending on experience. This position provides an excellent opportunity for professional growth and development in a dynamic industry.



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