Regulatory Specialist

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My Client a Global Medical Device Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Specialist on a permanent basis to be based at their offices in Cambridge.The Regulatory Specialist will ensure compliance of my client's products within relevant markets. Work alongside and liaise with Regulatory authorities/distributors to facilitate registrations and submissions.Key Responsibilities:Completion of paperwork and other requirements for regulatory submissions Collation of technical file documentation such as risk assessment summaries and product specificationsLiaising with product managers to ensure timely completion of data analysis for performance evaluation studiesLiaising with distributors to assist with registrations and any necessary paperwork to facilitate importing products.Legalisation of documentsCoordination of detailed risk assessmentsCarrying out regulatory reviews of quality system documentation and marketing materials as requiredAny other tasks, within reason, as requested by their line managerSkills/Experience Required:Life Sciences Degree QualifiedExperienced working in Regulatory Affairs within an IVD environmentHands on experience working to ISO13485 and CFR 820 Quality SystemsWorking knowledge of IVD Technical Files, Risk Management and CE Marking. If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.