Remote SaMD Software Certification Specialist

BSI; York and North Yorkshire; Remote; GBP 80,000 - 100,000; Full time

Job summary

A leading global standards organization is seeking a Technical Specialist to manage a portfolio of Medical Device CE marking schemes. The role requires 4+ years of software medical device experience, ideally in product design or testing, and involves delivering technical documentation assessments and project management. This remote position offers a competitive salary and robust benefits, emphasizing professional development opportunities.

Benefits

Competitive salary

Ample annual leave

Professional development opportunities

Qualifications

• 4+ years of Software Medical Device experience in a technical role.
• Ability to interpret International and National standards for software medical devices.
• Understanding of Risk Management and FMEA.

Responsibilities

• Plan and deliver Technical File Assessments and Unannounced Audits.
• Manage client projects and make certification recommendations.
• Act as technical support for business development.

Skills

Software Medical Device experience

Interpretation of International standards

Understanding of Risk Management

Broad technical understanding of medical devices

Education

Bachelor’s degree in relevant fields

Job description

A leading global standards organization is seeking a Technical Specialist to manage a portfolio of Medical Device CE marking schemes. The role requires 4+ years of software medical device experience, ideally in product design or testing, and involves delivering technical documentation assessments and project management. This remote position offers a competitive salary and robust benefits, emphasizing professional development opportunities.