Remote Technical Specialist — Active Medical Devices

The British Standards Institution (BSI); Greater London; Hybrid; GBP 59,000 - 78,000; Full time

Job summary

The British Standards Institution (BSI) is seeking a Technical Specialist & Scheme Manager for Active Devices to work remotely on a global basis. You will assess documentation, manage CE certification processes and provide specialist regulatory support across the certification life cycle for active medical devices.

The role requires four years of healthcare or related experience, a relevant engineering degree, and familiarity with MDR/IEC standards.

Qualifications

• Four years' professional experience in healthcare products or related activities (manufacturing, auditing, research).
• Experience in design, manufacture, testing or use of the device or technology to be assessed preferred.
• Familiarity with EU MDR 2017/745 and/or EU Medical Devices Directive 93/42/EEC is advantageous.
• Awareness of IEC 60601 and ISO 14971 risk management standards.

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 and determine auditing requirements.
• Provide regulatory, operational and strategic support to scheme managers and products specialists.
• Provide leadership and mentoring on medical devices topics to the team.

Skills

Interpersonal communication

Prioritization

Regulatory knowledge

Engineering background

Education

Bachelor's degree in biomedical engineering

Job description

The British Standards Institution (BSI) is seeking a Technical Specialist & Scheme Manager for Active Devices to work remotely on a global basis. You will assess documentation, manage CE certification processes and provide specialist regulatory support across the certification life cycle for active medical devices.

The role requires four years of healthcare or related experience, a relevant engineering degree, and familiarity with MDR/IEC standards.