We exist to create positive change for people and the planet. Join us and make a difference too! We currently have an exciting opportunity in our Medical Device Notified Body to join our existing team of Internal Clinicians. Specifically for this role, we are looking for a General Practitioner, Family Doctor, or Intensivist.

Responsibilities

Using your medical expertise, you will collaborate closely with internal clinical teams to review manufacturers' technical documentation and clinical evaluation reports, assessing whether the clinical evidence supporting a medical device is sufficient in both quality and quantity. You will contribute essential clinical expertise within your medical specialism to medical device conformity assessments, including evaluation of:

• equivalence rationales and risk assessments
• appropriateness of clinical claims, indications, and contraindications for use, as well as user information and warnings
• adequacy of endpoints, follow-up, and clinical evaluation data. You will also evaluate post-market surveillance and post-market clinical follow-up (PMCF) activities to ensure they adequately demonstrate the ongoing safety, performance, and clinical benefit of the device. Working closely with our Project Management and Operations teams, you will support the coordination and allocation of work to appropriately qualified medical experts across relevant clinical disciplines. You will review incoming applications and determine their suitability for clinical assessment, ensuring they are assigned to the most appropriate medical expertise to support efficient and effective conformity assessment activities. Additionally, you will mentor BSI technical/clinical staff and external clinical experts, ensuring consistency and rigor in clinical data reviews, help develop internal “best practice” guides for clinical evaluation and data requirements within your specialism, act as clinical support to the commercial/Marketing team when required, provide internal and external training in areas of expertise, and appoint external experts for novel technologies.

Requirements

To be successful in the role, you will need to:

• Be an experienced clinician who has worked with a variety of medical devices, complementary to our existing in-house expertise.
• Demonstrate competency with a range of devices and their indications for use.
• Have experience analyzing clinical data.
• Possess a good knowledge of clinical investigations.

What We Offer

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development, and additional benefits depending on your location. In the UK, the salary for this position ranges from £59,000 to £85,000 annually. This is a remote position that can be based in Europe. As compensation varies by country and local market conditions, salary details will be discussed with candidates prior to the interview stage. 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.

About Us

BSI is a business improvement and standards company, recognized for over a century 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 fulfill theirs. Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between – to accelerate progress towards a better society and a sustainable world. BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.