Remote SaMD Software Certification Specialist

BSI; City Of London; Remote; GBP 80,000 - 100,000; Full time

Job summary

A leading business improvement and standards organization is seeking a Technical Specialist to manage medical device compliance and CE marking schemes. The role involves extensive interaction with global manufacturers, conducting technical assessments, and providing expert guidance within the field of software medical devices. Applicants should have over 4 years of experience and a relevant degree. Competitive salary and robust benefits are offered, along with opportunities for professional development.

Benefits

Competitive salary

Ample annual leave

Professional development opportunities

Qualifications

• 4+ years of experience in a technical capacity related to software medical devices.
• Solid understanding of regulatory standards for medical device design.
• Experience in product design, development, or testing.

Responsibilities

• Plan and deliver Technical File Assessments and Audits.
• Manage client projects and provide certification recommendations.
• Act as technical support for business development.
• Perform compliance checks at medical device manufacturers.

Skills

Software Medical Device experience

Risk Management and FMEA understanding

Interpretation of standards

Broad technical understanding of medical devices

Education

Degree in relevant field

Job description

A leading business improvement and standards organization is seeking a Technical Specialist to manage medical device compliance and CE marking schemes. The role involves extensive interaction with global manufacturers, conducting technical assessments, and providing expert guidance within the field of software medical devices. Applicants should have over 4 years of experience and a relevant degree. Competitive salary and robust benefits are offered, along with opportunities for professional development.