Technical Specialist - Active Medical Devices

BSI

4d•£58,500 - £78,000•Remote

About The Position

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.

Requirements

Four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
Bachelor’s or higher degree in a discipline relevant to the medical device industry. This may include electronic/electrical, electro-mechanical or biomedical engineering or medical physics.
Familiarity with the Medical Devices Regulation (EU)2017/745 and/ or Medical Devices Directive 96/42/EEC is an advantage.
At minimum, an awareness of the requirements of IEC 60601 family of standards and the risk management standard ISO 14971.
Understanding of the principles of design control and risk management.
Strong interpersonal communication skills.
Ability of prioritizing and executing individual workload.

Nice To Haves

Candidates with professional experience gained in accredited testing laboratories and a broad exposure to a range of active medical devices have been successful in the role.

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 certification activities for a portfolio of medical device manufacturers, including determination of auditing requirements and making recommendations for the issue and maintenance of CE certifications.
Provide specialist regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes.
Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.