SaMD Technical Lead & Certification Specialist (Remote)

BSI; Germany (OH); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Flexible working hours

Generous leave

Global remote role

Job summary

BSI is seeking a Technical Specialist, Scheme Manager, and Clinical Evaluation Specialist for SaMD on a home-based, global basis. You will plan and execute technical reviews, certifications, and unannounced audits across multiple regions, acting as a primary client contact and technical expert.

The role requires 4+ years of software medical device experience, strong standards knowledge, and risk management skills.

Qualifications

• 4+ years of software medical device experience in a technical role (design, development or testing).
• Interpretation and application of international/national standards for software medical devices.
• Understanding of risk management and FMEA for software medical devices.
• Broad technical understanding of medical devices and industry trends.

Responsibilities

• Plan and deliver Technical File Assessments, Design Examinations and Unannounced Audits for EC Certification.
• Lead client projects, act as primary contact, and recommend CE/UKCA and ISO 13485 Certification.
• Provide technical support to the commercial team for business development worldwide.
• Perform unannounced visits to manufacturers to verify certification compliance.
• Collaborate with Line Manager and team leaders to provide expert reviews.

Skills

Software medical device experience

Education

Bachelor's degree in a relevant field

Job description

BSI is seeking a Technical Specialist, Scheme Manager, and Clinical Evaluation Specialist for SaMD on a home-based, global basis. You will plan and execute technical reviews, certifications, and unannounced audits across multiple regions, acting as a primary client contact and technical expert.

The role requires 4+ years of software medical device experience, strong standards knowledge, and risk management skills.