Regulatory Affairs Contract Medical Devices jobs

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 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.

• 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.

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.

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development. The salary for this position for the UK can range from £58,500- £78,000 annually; actual compensation is based on various factors, including but not limited to, the candidate’s competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons. If you are based in the EU, your recruiter can inform you of the local salary banding which differs per country based on various factors.

Do you believe the world deserves excellence?

We are proud to be the business improvement company for other organisations to become more sustainable and resilient and finally to inspire trust in their products, systems, services, and the world we live in.

Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cyber security expertise for all industries: from aerospace and automotive to food, construction, energy, healthcare, IT and trade sectors. Incorporated by Royal Charter, we’re truly impartial, and home to the ultimate mark of trust, the Kitemark.

Through our unique combination of consulting, training, assurance and regulatory services we bring solid and broad knowledge to every company.

If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family!

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. BSI is a community where everyone can thrive.

If you require any reasonable accommodations to be made on account of a disability or impairment throughout out our recruiting process, please inform your Talent Acquisition Partner.

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