Regulatory Affairs and Quality Assurance Assistant - Medical Devices - CambridgeDue to the growth of a medical devices company based in Cambridge, a new Regulatory Affairs and Quality Assurance Assistant is needed to work with and support the company's Quality Assurance and Regulatory Affairs Manager.
The team provides quality assurance and regulatory affairs advice on the creation of recent products and the improvement of existing technologies.ResponsibilitiesSupport the QA & Regulatory Affairs Manager in day‐to‐day operations.Provide critical advice to the R&D; team on the development of medical devices.Ensure compliance with FDA 510k, ISO ***** and FDA 21 CFR Part 820 standards.Relay information to teams responsible for regulatory submissions.QualificationsKnowledge of medical devices regulation (ISO *****, FDA 510k) and, ideally, 21 CFR Part 820.Experience in medical devices R&D; or design team; regulatory affairs or quality assurance background beneficial.Understanding of QMS processes.Degree (1–2:1) in engineering or sciences, though experience is weighted more heavily.BenefitsCareer progression, competitive salary, comprehensive benefits package, and share options.
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📌 Regulatory Affairs And Quality Assurance Assistant - Cambridge (Western Australia)
🏢 Newton Colmore Consulting
📍 Western Australia