Regulatory Affairs Specialist

Cure Talent Ltd • Permanent • Bromsgrove, Worcestershire, England, United Kingdom • £45,000 - £50,000 / year • 1w ago

Cure Talent are delighted to be partnered with an established medical device manufacturer with a long-standing portfolio of Class I and Class IIa medical devices supplied across the UK and European markets. Due to continued growth, they are now looking to appoint a Regulatory Affairs Specialist to join their Quality & Regulatory team based in Bromsgrove.

As the new Regulatory Affairs Specialist, you will play a key role in ensuring ongoing compliance with UK MDR and EU MDR requirements, supporting products throughout the full lifecycle from development through to post-market activities. Working closely with the QA Manager, you will be responsible for maintaining technical documentation, supporting regulatory submissions, liaising with regulatory bodies, and contributing to the continued development of the Quality Management System.

To be successful as the new Regulatory Affairs Specialist, you will have experience working within Regulatory Affairs in the medical device industry, with a strong understanding of UK MDR, EU MDR, UKCA and ISO 13485. You will have hands-on experience preparing technical documentation and supporting regulatory compliance activities within a regulated environment.

Key Responsibilities

Support the implementation and continual improvement of the Quality Management System in line with ISO 13485
Prepare, review and maintain Technical Files, Design Dossiers and GSPR checklists in accordance with UK MDR and EU MDR requirements
Support the preparation and maintenance of regulatory compliance documentation across the product portfolio
Prepare risk management documentation and Clinical Evaluation Reports
Coordinate Post Market Surveillance and Post Market Clinical Follow-up activities

Experience and Skills Required

Proven Regulatory Affairs experience within the medical device industry
Strong working knowledge of UK MDR, EU MDR 2017/745, UKCA and ISO 13485
Experience preparing and maintaining Technical Files and regulatory documentation
Experience supporting regulatory submissions and compliance activities
Experience working with Class I and Class IIa medical devices
Degree in Life Sciences, Engineering, Biomedical Science or a related discipline

If you have the necessary skills and experience, please get in touch with Kris Holmes today or click apply now.