Remote SaMD CE Certification Specialist

BSI; Remote; GBP 80,000 - 100,000; Full time

Job summary

A leading standards organization seeks a Technical Specialist to manage medical device CE marking schemes. The role involves delivering technical assessments, managing client projects, and providing expertise in software medical devices. Candidates should have over 4 years of relevant experience and a degree in a related field. The organization offers competitive salary, annual leave, and strong development programs for its experts.

Benefits

Competitive salary

Ample annual leave

Professional development opportunities

Qualifications

• 4+ years of experience in software medical device area, focusing on design, development, or testing.
• Ability to interpret International and National standards regarding medical devices.
• Knowledge of Risk Management and FMEA related to software medical devices.

Responsibilities

• Deliver Technical File Assessments, Design Examinations, and Unannounced Audits for EC Certification.
• Manage client projects, ensuring timely certification recommendations and high client satisfaction.
• Assist the commercial team in business development efforts.

Skills

Software Medical Device experience

Interpretation of standards

Risk Management and FMEA expertise

Technical understanding of medical devices

Education

Bachelor’s degree in relevant field

Job description

A leading standards organization seeks a Technical Specialist to manage medical device CE marking schemes. The role involves delivering technical assessments, managing client projects, and providing expertise in software medical devices. Candidates should have over 4 years of relevant experience and a degree in a related field. The organization offers competitive salary, annual leave, and strong development programs for its experts.