Technical Reviewer - Medical Devices

Position: Technical Reviewer - Active Medical Devices
Job Title
Technical Specialist & Scheme Manager - Active Devices
Location
Home-based position located in the UK or Europe with up to 20% travel for 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.

Qualifications

A minimum of 5 years of design and development or research and development or testing experience with a variety of active medical devices.
Bachelor’s degree (or higher) in a discipline relevant to medical device manufacture and use such as 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.

Benefits
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.

How to Apply

Interested?

To apply for this role please submit your application today and take the next step in your career as a Technical Reviewer with BSI.
D&I Policy
BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. If you require any reasonable accommodations to be made on account of a disability or impairment throughout our recruiting process, please inform your Talent Acquisition Partner.
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