BSI
Technical Specialist - Active Medical Devices
Get notified of more jobs like this · No spam, ever
How your CV stacks up
Upload your CV to see how well it fits this job role
?%
Technical Specialist & Scheme Manager - Active Devices
Location: Global Homebased
We exist to create positive change for people and the planet. Join us and make a difference too!
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.
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.
Reasons to use Rodeo
Start with a chat, not a search bar
Grad scheme, placement, apprenticeship? Not sure what you want yet — that's fine. Your agent talks it through with you and turns "I have no idea" into a shortlist.
It searches the market for you
Every day your agent scans the market matching roles against what actually matters to you, not just keywords on a CV.
Only hits
No noise. No "maybe this fits." Just roles with a clear explanation of why they're right — and where to focus when applying.
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.
- 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.
About BSI
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.
Get help with your application
Your very own career expert that helps elevate your application to the next level.
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.
Benefits
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.
Apply Now
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.
“It took my CV and asked me questions relevant to understanding what kind of jobs to suggest for me. Suggestions were almost perfect. Jobs were exactly what I’ve been looking for.”
Jessica, London
Location