Regulatory Affairs Specialist

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
• Liaise with the MHRA, Notified Bodies and external regulatory partners
• Support management review activities and Notified Body audit preparation
• Monitor changes to relevant regulations and standards and support implementation across the business
• Provide regulatory guidance and training to cross-functional teams
• Support internal and external audits as required

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.