Key Responsibilities:
- Perform technical assessments of active medical devices, ensuring compliance with MDR 2017/745 and international regulatory standards.
- Conduct conformity assessments, design dossier reviews, and clinical evaluations for medical devices.
- Lead and participate in regulatory audits (ISO 13485, MDSAP, MDR) as a Lead Auditor or Technical Assessor.
- Evaluate risk management processes (ISO 14971), software validation (IEC 62304), and usability engineering (IEC 62366).
- Work closely with regulatory teams, manufacturers, and stakeholders to ensure compliance with European and international regulations.
- Prepare technical reports, audit findings, and certification recommendations in line with regulatory expectations.
- Support post-market surveillance and vigilance investigations for active medical devices.
- Deliver internal training and regulatory guidance to support certification processes.
Requirements:
- A degree in engineering, biomedical sciences, physics, or a related technical field (e.g., MSc, PhD preferred).
- Extensive experience in the design, development, testing, or regulatory assessment of active medical devices.
- Qualification as a Lead Auditor (ISO 13485, MDSAP) is highly desirable.
- Strong knowledge of electromedical devices, software as a medical device (SaMD), and high-risk active devices.
- Experience with Notified Bodies, Competent Authorities, or Regulatory Agencies is highly desirable.
- Ability to interpret clinical data, risk management files, and performance evaluation reports.
- Excellent report writing, documentation, and analytical skills.
