At a Glance
- Tasks: Own regulatory submissions and manage lifecycle activities for IVD products.
- Company: Medibeam, a leading company in the medical technology sector.
- Benefits: Competitive salary, career development opportunities, and a supportive work environment.
- Other info: Site-based role in vibrant Cambridge with opportunities for growth.
- Why this job: Make a real impact in healthcare by ensuring compliance and driving process improvements.
- Qualifications: Experience in regulatory affairs and knowledge of ISO 13485 QMS.
The predicted salary is between 63000 - 77000 £ per year.
Medibeam in Cambridge is seeking a Regulatory Affairs Specialist to own regulatory submissions and IVDR/IVDD activities for IVD products.
You will prepare regulatory and technical documentation and help manage lifecycle activities across multiple markets.
The role focuses on ensuring ongoing compliance within an ISO 13485 QMS environment, supporting PMS and cross-portfolio regulatory work, and driving process improvements to enhance efficiency.
This is a site-based position in Cambridge.
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IVD Regulatory Specialist — Submissions & IVDR (Cambridge) employer: Medibeam
Medibeam is an excellent employer for those looking to grow within the MedTech industry, offering a supportive culture that prioritises employee development and training. With a well-established ISO 13485 quality management system, employees can expect to gain invaluable experience and skills in QA processes while enjoying the flexibility of a hybrid work model after the initial onboarding period. The company's commitment to fostering talent makes it an ideal place for individuals eager to advance their careers in a meaningful and rewarding environment.
