Newton Colmore in Cambridge is seeking a Regulatory Affairs Engineer to support medical devices across development projects. You will work with design engineers and project teams to ensure regulatory thinking informs product architecture, design decisions and verification strategies from concept through release.
You will apply knowledge of ISO 9001, ISO 13485 and FDA 21 CFR 820, contribute to design controls, track regulatory changes, and support audits, ensuring robust compliance while enabling
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Regulatory Affairs Engineer, Medical Devices — Cambridge employer: Newton Colmore
Newton Colmore is an exceptional employer, fostering a collaborative and innovative work culture where every team member's input is valued. Located in a dynamic environment, the company offers tailored benefits packages, monetary bonuses, and ample opportunities for professional growth, making it an ideal place for engineers passionate about pushing the boundaries of technology in high-performance computing.
