Remote SaMD Software Certification Specialist

BSI; Tees Valley; Remote; GBP 45,000 - 60,000; Full time

Job summary

A leading standards organization is seeking a Technical Specialist to manage a portfolio of medical device CE marking schemes. The role involves technical documentation assessments, project management, and ensuring compliance with certification standards. Ideal candidates have 4+ years in software medical devices and a relevant bachelor's degree. This position offers a competitive salary and robust benefits, with remote work options.

Benefits

Competitive salary

Ample annual leave

Professional development opportunities

Qualifications

• 4+ years of experience in a technical capacity related to software medical devices.
• Ability to interpret International and National standards.
• Familiarity with Risk Management and FMEA.

Responsibilities

• Plan and deliver Technical File Assessments and Audits.
• Manage client projects and ensure certification compliance.
• Act as technical support for the commercial team.

Skills

Software Medical Device experience

Interpretation of standards

Understanding of Risk Management

Broad technical understanding of medical devices

Education

Bachelor’s degree in relevant field

Job description

A leading standards organization is seeking a Technical Specialist to manage a portfolio of medical device CE marking schemes. The role involves technical documentation assessments, project management, and ensuring compliance with certification standards. Ideal candidates have 4+ years in software medical devices and a relevant bachelor's degree. This position offers a competitive salary and robust benefits, with remote work options.