We exist to create positive change for people and the planet. Join us and make a difference too!
BSI is a designated European Notified Body, an accredited ISO 13485 certification body, and a recognized Auditing Organization under MDSAP. Are you looking to join a dynamic global industry leader that can boast nearly 120 years of excellence, growth, and continuing innovation? Do you hold yourself to the highest of standards? If yes, then we would love to hear from you.
Our Technical Specialists are industry experts that are analytical, communicative, diligent, and always curious. If you are looking for a career change and want to make an impact on patient safety – this may be a great fit for you! This is a home-based position with up to 25% travel.
Essential Responsibilities:
Deliver Medical Device CE Marking technical reviews under MDD and MDR requirements, scheme management and ISO 13485 QMS assessment services.
Provide advice and support on certifications in area of expertise that may have a regulatory challenge.
Participate in client meetings to facilitate CE marking processes.
Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.
Provide “Technical Sales/Networking” support as needed
The ideal candidate will possess the following characteristics:
Bachelor's degree or higher in a discipline relevant to medical device design, manufacture and use, or equivalent qualification.
At least five (5) years' post-graduate experience in the design and development of medical devices in area of experience, including the principles of design control, risk management and performance and/or clinical evaluation
Knowledge of medical device regulations.
Awareness of certification business processes, the application of quality management standards, and audits
The salary for this position can range from $120,000 to $154,000 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. BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.
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About Us
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.
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.
Skills Required
- Bachelor's degree or higher in a relevant discipline
- At least five years post-graduate experience in medical device design and development
- Knowledge of medical device regulations
- Awareness of certification business processes and quality management standards
BSI Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about BSI and has not been reviewed or approved by BSI.
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Flexible Benefits — Flexible benefits are positioned as part of the MyReward approach, allowing tailoring based on local eligibility and individual needs. Core elements like life assurance, income protection, and EAP access are framed as consistent pillars even as specifics vary by country.
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Leave & Time Off Breadth — Leave offerings are described as generous in certain markets, including annual leave starting around 27 days where that is standard and, in some U.S. postings, about four weeks of PTO plus a set holiday calendar. Additional time-off practices like occasional year-end office closure are also described as part of the overall package in some teams.
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Wellbeing & Lifestyle Benefits — Well-being support is presented as visible at the corporate level, including EAP access and expanded programs such as menopause support and mental-health first aid. Flexible work under “Smart Working” is repeatedly positioned as a work–life balance and inclusion lever that complements the total rewards package.
BSI Insights
What We Do
BSI is your business improvement partner. We have shaped best practice for over 100 years, partnering with organizations to accelerate progress and create impact for a fairer society and sustainable world
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