MedTech Regulatory Affairs Specialist – ISO 13485 & CE Expert

MedTech Regulatory Affairs Specialist – ISO 13485 & CE Expert

Full-Time No working from home possible
Newton Colmore

Newton Colmore in Cambridgeshire is seeking a Regulatory Affairs Specialist to join a growing MedTech team. You will ensure compliance across ISO 13485, CE Marking and related UK/EU standards while supporting design and manufacturing processes.

The role involves internal audits, maintaining technical files, and shaping regulatory strategy for Europe, North America and APAC. Ideal candidates have 2–5 years in QA/RegAff, an engineering or biomedical background and a passion for precise, compliant

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MedTech Regulatory Affairs Specialist – ISO 13485 & CE Expert employer: Newton Colmore

Join a dynamic and innovative medical devices company in Cambridge, where your contributions will directly impact the development of life-changing technologies. With a strong focus on employee growth, this organisation offers excellent career progression opportunities, a competitive salary, and a comprehensive benefits package, all within a collaborative work culture that values your input in both regulatory affairs and quality assurance. Be part of a team that not only meets industry standards but also strives to improve lives globally.

Newton Colmore

Contact Details:

Newton Colmore Recruitment Team