Remote SaMD Certification Specialist

BSI; Italia; In loco; EUR 78.795 - 105.060; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible working hours

Learning and development opportunities

Global exposure

Descrizione del lavoro

BSI is seeking a Technical Specialist, Scheme Manager, and Clinical Evaluation Specialist for SaMD to support EC Certification worldwide. Based remotely, you will lead technical file assessments, design examinations and unannounced audits to ensure regulatory compliance.

You will interpret international standards for software medical devices, apply risk management and FMEA concepts, and collaborate with product teams to advance certifications and market access globally.

Competenze

• 4+ years of software medical device experience in a technical capacity (design, development, testing).
• Interpretation and application of International and National standards for software medical devices.
• Understanding of Risk Management and FMEA of Software Medical Devices.
• Broad technical understanding of medical devices and industry trends.

Mansioni

• Plan and deliver Technical File Assessments, Design Examinations and Unannounced Audits to support EC Certification.
• Manage client projects 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.

Conoscenze

Software Medical Device experience

Standards interpretation

Risk Management & FMEA

Broad technical understanding

Formazione

Bachelor’s degree in relevant field

Descrizione del lavoro

BSI is seeking a Technical Specialist, Scheme Manager, and Clinical Evaluation Specialist for SaMD to support EC Certification worldwide. Based remotely, you will lead technical file assessments, design examinations and unannounced audits to ensure regulatory compliance.

You will interpret international standards for software medical devices, apply risk management and FMEA concepts, and collaborate with product teams to advance certifications and market access globally.