At a Glance
- Tasks: Ensure compliance with UK and EU regulations for medical devices throughout their lifecycle.
- Company: Established medical device manufacturer with a strong portfolio in the UK and Europe.
- Benefits: Competitive salary, career development opportunities, and a supportive team environment.
- Other info: Dynamic role with opportunities for professional growth in a regulated environment.
- Why this job: Join a growing team and make a real impact in the medical device industry.
- Qualifications: Experience in Regulatory Affairs and knowledge of UK MDR, EU MDR, and ISO 13485.
The predicted salary is between 35000 - 45000 £ per year.
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
- 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.
Regulatory Affairs Specialist in Worcester employer: Cure Talent
Join a forward-thinking medical device manufacturer in Bromsgrove, where your expertise as a Regulatory Affairs Specialist will be valued and nurtured. With a strong commitment to employee development, a collaborative work culture, and a focus on compliance excellence, this company offers a unique opportunity to contribute to innovative healthcare solutions while enjoying a supportive environment that prioritises growth and professional advancement.
