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.