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Job Location | Bath |
Education | Not Mentioned |
Salary | Salary negotiable |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , full-time |
Performing tasks relating to regulatory affairs, preparation of regulatory documents involving risk, post market surveillance and ex-vivo verification testing.Client DetailsMy client is a rapidly growing Medical Devices business, looking to improve patient care through Advanced Energy.Description- CE marking and 510(k) submissions- Technical files for EU and US- Development of device labelling- Device registration / global notified bodies- Write and maintain regulatory procedures- Support post-market surveillance and vigilance- With a good working knowledge of ISO 10993, provide clear direction to the project team on the requirements for chemical and biological compatibilityProfile- Regulatory Affairs experience within medical devices- Experience with the EU and US standards (Sterilisation and Biocompatibility) of medical devices.- 510K Submission experience- Strong technical understanding- Experience writing technical documentationJob OfferCompetitive salary packageHybrid working (Remote 2-3 days a week)Excellent opportunity to be apart of a rapidly expanding business