Medical Device Regulatory Affairs Manager

3 days ago


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

We are seeking a skilled Medical Device Regulatory Affairs Manager to join our Quality team at Riverside Medical Packaging Company Ltd. As a key member of the team, you will be responsible for assisting with the maintenance of the company's compliance to quality standards, EU & UK medical device regulations, and supporting the continued effectiveness of the Quality Management System (QMS).

About the Role
  • Salary: £40,000 - £55,000 per annum (depending on experience)
  • Location: Office based (primarily), with quarterly bonus and yearly bonus opportunities

Your responsibilities will include assisting with the upkeep and creation of Technical Files, conducting literary research, and controlling product specifications. You will have a strong analytical mindset, excellent communication skills, and be able to work effectively in a fast-paced environment. Ideally, you will have knowledge and experience with QMS and Technical files.

Key Responsibilities:
  • Assisting with the upkeep and creation of Technical Files
  • Conducting literary research
  • 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

Riverside Medical Packaging offers a collaborative atmosphere where you will thrive as a member of a supportive team dedicated to excellence and continuous improvement. Every team member plays a critical role in ensuring the quality and safety of products in accordance with our client's needs.



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