Technical Reviewer - Active Medical Devices

Remote, South Africa

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Job title: Technical Specialist & Scheme Manager - Active Devices

Location: Global Homebased

BSI is seeking experienced medical device professionals to join our Active Medical Devices team as a home-based Technical Specialist and Certification Scheme Manager (Final Reviewer). If you have hands-on experience in the research, design, manufacture or testing of active devices we'd love to hear from you.

As a Technical Reviewer, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market. This position applies a mix of engineering and design knowledge, newfound regulatory expertise, English writing skills, client and project management. You will assess cutting edge technology that will make a difference in patient health and safety and broaden your technical knowledge through ongoing training.

Responsibilities:

Review and evaluate medical device technical and clinical documentation in your areas of competence to assess compliance with MDD 93/42/EEC, MDR 2017/745 and UK MDR 2012 schemes.

Manage...