Medical Device Regulatory Expert

18 hours ago


Derby, Derby, United Kingdom Riverside Medical Packaging Company Ltd Full time

As a Medical Device Regulatory Expert at Riverside Medical Packaging Company Ltd, you will play a critical role in ensuring the quality and safety of our products. We are seeking a highly skilled individual with knowledge and experience in Technical files, including required content and creation.

The ideal candidate will have previous experience in the medical manufacturing industry, but transferable skills and a willingness to learn are also valued. You will work in a collaborative atmosphere where you will thrive as a member of a supportive team dedicated to excellence and continuous improvement.

Key Responsibilities:

  • Assisting with the upkeep and creation of Technical Files
  • Conducting literary research
  • Assisting with on-time fulfilment of compliance and regulatory changes
  • Controlling and maintaining product specifications
  • Maintaining effective communications with EU representatives, Economic Operators, Distributors, and the Group compliance team on matters relating to compliance
  • Communicating with competent authorities on matters relating to EUDAMED, incidents, and recalls
  • Providing support with product data collection and reviews
  • Participating in the change control process for new product introduction and alterations
  • Adhering to the Company's hygiene and quality standards (GMP) at all times
  • Facilitating the development of an open productive culture where people take pride and responsibility in what they do
  • Demonstrating good employee relations within the team and to other departments

We offer a competitive salary of £55,000 - £70,000 per annum, depending on experience.



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