Medical Device Compliance Specialist

5 days ago


Keighley, Bradford, United Kingdom Cure Talent Full time

Cure Talent is seeking an experienced Senior Regulatory Affairs Associate to join their team in West Yorkshire. As a key member of the regulatory affairs department, you will play a vital role in ensuring the company's medical devices comply with relevant regulations and standards.

Key Responsibilities:

  1. Develop and maintain technical files for medical devices, ensuring they meet industry standards and regulatory requirements.
  2. Implement post-market surveillance strategies to monitor and evaluate product performance in the market.
  3. Conduct internal audits to ensure ongoing compliance with MDD, MDR, and ISO 13485 standards.

Requirements and Qualifications:

  • Prior experience working in the Medical Device sector with a focus on regulatory affairs.
  • Strong understanding of tech file management, creation, and maintenance.
  • Ability to develop and implement effective post-market surveillance strategies.
  • Familiarity with MDD, MDR, and ISO 13485 standards.

Salary and Benefits: We offer a competitive salary of £55,000 - £65,000 per annum, dependent on experience, along with a range of benefits.



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