Active Medical Devices Specialist & Certification Lead

BSI; Germany (OH); On-site; USD 120,000 - 150,000; Full time

Job summary

BSI is seeking an experienced medical device professional to join our Active Medical Devices team as a Technical Specialist and Certification Scheme Manager (Final Reviewer). This global, home-based role requires hands-on experience in research, design, manufacture or testing of active devices.

You will review technical and clinical documentation for compliance with EU MDR/MDD, manage certification activities, and provide regulatory support to scheme managers and product specialists across the

Qualifications

• Four years of professional experience in healthcare products or related activities.
• Bachelor’s degree in a discipline relevant to the medical device industry such as electronic/electrical, electro‑mechanical, 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.
• Awareness of IEC 60601 family of standards and ISO 14971 risk management.
• Understanding of design control and risk management principles.

Responsibilities

• Review technical and clinical documentation 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 and CE certifications.
• Provide regulatory, operational and strategic support to scheme managers and product specialists.
• Mentor and provide leadership in medical devices expertise.

Skills

Healthcare device experience

Regulatory knowledge

Quality system & risk management

Documentation review & CE schemes

Stakeholder communication

Education

Bachelor's degree in biomedical/engineering or medical physics

Job description

BSI is seeking an experienced medical device professional to join our Active Medical Devices team as a Technical Specialist and Certification Scheme Manager (Final Reviewer). This global, home-based role requires hands-on experience in research, design, manufacture or testing of active devices.

You will review technical and clinical documentation for compliance with EU MDR/MDD, manage certification activities, and provide regulatory support to scheme managers and product specialists across the