SaMD Technical Specialist & Certification Lead

BSI; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with company contribution

Paid parental leave

Disability insurance

Flexible benefits

Job summary

BSI is seeking a Technical Specialist, Scheme Manager and Clinical Evaluation Specialist for SaMD. Location: Home-based – global, with occasional travel as required.

You will report to the Technical Team Manager and collaborate across borders to ensure robust certification processes. Responsibilities include planning and delivering technical file assessments, design examinations, unannounced audits, and issuing recommendations for CE, UKCA and ISO 13485 certificates.

Qualifications

• 4+ years of software medical device experience in a technical capacity (design, development or testing).
• Experience interpreting International and 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.
• Manage client projects as primary contact and make certification recommendations for CE, UKCA and ISO 13485 issuance.
• Provide technical support to the commercial team for business development and marketing worldwide.
• Perform unannounced visits to check compliance with certification.
• Collaborate with Line Manager and team leaders for technical reviews.

Skills

Software medical devices

Risk management

FMEA

Standards interpretation

Medical devices knowledge

Education

Bachelor's degree or equivalent in a relevant field

Job description

BSI is seeking a Technical Specialist, Scheme Manager and Clinical Evaluation Specialist for SaMD. Location: Home-based – global, with occasional travel as required.

You will report to the Technical Team Manager and collaborate across borders to ensure robust certification processes. Responsibilities include planning and delivering technical file assessments, design examinations, unannounced audits, and issuing recommendations for CE, UKCA and ISO 13485 certificates.