Technical Specialist - Active Medical Devices

Technical Specialist & Scheme Manager - Active Devices

BSI is seeking experienced R&D Engineers to join our Active Medical Devices team as a home-based Technical Specialist & Scheme Manager (Technical Reviewer). If you have hands on experience in the Research, Design or Manufacture of Active Medical 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 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.

To be successful in this role, you will have:

• 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 degree (or higher) in a discipline relevant to medical device manufacture and use. This may include electronic/electrical, electro-mechanical or biomedical engineering or medical physics.
• Thorough knowledge of Medical Device regulation; at minimum an awareness of the requirements of IEC 60601 Third Edition 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.

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development and a wide range of flexible benefits that you can tailor to suit your lifestyle.

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives. Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments. Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.