Technical Specialist - Active Medical Devices

BSI; United States; Remote; USD 78,000 - 104,000; Full time

Benefits offered by this job

Flexible working hours

Ongoing training and development

Job summary

BSI is seeking a Technical Specialist & Scheme Manager for Active Medical Devices on a global homebased role. You will review regulatory documentation, manage certification activities, and provide strategic support across CE marking schemes for medical devices.

Ideal candidates have 4+ years in healthcare product fields, a relevant degree, and familiarity with EU MDR/UK MDR. Strong communication and project management skills are essential for success in a global, flexible work environment.

Qualifications

• Four years’ professional experience in healthcare products or related activities
• Bachelor’s or higher degree in a discipline relevant to medical device industry
• Familiarity with Medical Devices Regulation (EU)2017/745 and/or Medical Devices Directive 96/42/EEC is an advantage
• Awareness of IEC 60601 and ISO 14971 risk management standards
• Understanding of design control and risk management principles
• Strong interpersonal communication skills

Responsibilities

• Review and evaluate medical device technical and clinical documentation for 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 auditing requirements and CE certifications
• Provide regulatory, operational and strategic support to scheme managers and product specialists
• Provide leadership and mentoring in areas of medical device competence

Skills

Regulatory knowledge

Interpersonal communication

Project management

English writing

Education

Bachelor's or higher in a relevant discipline

Job description

We exist to create positive change for people and the planet. Join us and make a difference too!

Job title: Technical Specialist & Scheme Manager - Active Devices

Location: Global Homebased

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.

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 thedesign, manufacture, testing or use of the device or technology to be assessedor related to the scientific aspects to be assessed.

• Bachelor’s or higher degree in a discipline relevant to the medical device industry. This may includeelectronic/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.

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 deservesexcellence?

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.

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, andengage 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 orimpairment throughout out our recruiting process,please inform your Talent Acquisition Partner.

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.