Remote SaMD CE Certification Specialist

BSI; Remote; GBP 100,000 - 125,000; Full time

Job summary

A leading global business improvement company is looking for a Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD in the UK. The role involves managing a portfolio of Medical Device CE marking schemes and delivering technical assessments. The ideal candidate will have a background in Software Medical Device experience and a relevant degree. You'll enjoy a competitive salary, extensive benefits, and opportunities for professional development, all while making a difference for clients worldwide.

Benefits

Competitive salary

Ample annual leave

Robust benefits

Professional development opportunities

Qualifications

• 4+ years of experience in a technical capacity related to Software Medical Devices.
• Knowledge of International and National standards for medical devices.
• Experience in Risk Management and FMEA for software devices.

Responsibilities

• Deliver Technical File Assessments, Design Examinations, and Audits.
• Manage client projects and provide compliance recommendations.
• Support business development efforts as a technical expert.

Skills

Software Medical Device experience

Interpretation of International and National standards

Understanding of Risk Management and FMEA

Broad technical understanding of medical devices

Education

Bachelor’s degree in relevant fields

Job description

A leading global business improvement company is looking for a Technical Specialist, Scheme Manager, Clinical Evaluation Specialist - SaMD in the UK. The role involves managing a portfolio of Medical Device CE marking schemes and delivering technical assessments. The ideal candidate will have a background in Software Medical Device experience and a relevant degree. You'll enjoy a competitive salary, extensive benefits, and opportunities for professional development, all while making a difference for clients worldwide.