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 continuous improvement and professional growth.
- Why this job: Join a growing team and make a difference in healthcare through regulatory excellence.
- Qualifications: Experience in Regulatory Affairs within the medical device industry and relevant degree.
The predicted salary is between 40000 - 50000 £ 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.
- Support the implementation and continual improvement of the Quality Management System in line with ISO 13485
- Support the preparation and maintenance of regulatory compliance documentation across the product portfolio
- Prepare risk management documentation and Clinical Evaluation Reports
- Proven Regulatory Affairs experience within the medical device industry
- 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
Regulatory Specialist and Senior Specialist in Bromsgrove employer: Cure Talent
Join a leading 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, the company offers a collaborative work culture that encourages innovation and continuous improvement, alongside competitive benefits and opportunities for career advancement within the thriving medical device sector. Be part of a team that is dedicated to ensuring compliance and quality in healthcare, making a meaningful impact on patients' lives across the UK and Europe.
