Key Responsibilities:
- Conduct technical file reviews, risk assessments, and clinical evaluations of non-active medical devices.
- Perform conformity assessments and certification evaluations under MDR 2017/745 and related standards.
- Lead and participate in regulatory audits (ISO 13485, MDSAP, MDR) as a Lead Auditor or Technical Assessor.
- Assess compliance with biocompatibility standards (ISO 10993), sterilization validation (ISO 11135, ISO 11137), and usability engineering (IEC 62366).
- Evaluate post-market surveillance (PMS), post-market clinical follow-up (PMCF), and vigilance reporting for non-active devices.
- Collaborate with regulatory teams, manufacturers, and stakeholders to ensure compliance with European and international regulations.
- Prepare audit reports, technical documentation reviews, and certification recommendations.
- Provide regulatory guidance and internal training to support certification processes.
Requirements:
- A degree in engineering, materials science, biomedical sciences, or a related technical field (e.g., MSc, PhD preferred).
- Extensive experience in the design, development, or regulatory assessment of non-active medical devices.
- Qualification as a Lead Auditor (ISO 13485, MDSAP) is highly desirable.
- Strong knowledge of implantable and high-risk non-active devices, such as orthopedic implants, surgical instruments, wound care, or dental materials.
- Experience with Notified Bodies, Competent Authorities, or Regulatory Agencies is highly desirable.
- Ability to analyze clinical evaluation reports (CER), risk management files, and performance data.
- Excellent technical writing, documentation, and analytical skills.
