Job Description: Medical Device Assessor & Lead Auditor - Active Devices
Location: Remote / Hybrid (Flexible)
Employment Type: Contract / Permanent
Industry: Medical Devices, Regulatory Affairs, Notified Body
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.
Desirable Skills:
- Experience with implantable medical devices, AI-driven technologies, or complex electromechanical systems.
- Familiarity with international regulatory frameworks (FDA 21 CFR 820, TGA, MHRA, NMPA, Health Canada).
- Strong presentation and training skills to support internal and external stakeholders.
Why Join?
- Work with a highly experienced regulatory team during a key transitional phase.
- Contribute to the certification and regulatory compliance of cutting-edge active medical devices.
- Flexible working arrangements with opportunities for contract or permanent employment.
If you are an experienced Medical Device Assessor or Lead Auditor with expertise in active devices, this role offers a chance to leverage your skills in a crucial regulatory environment.
Interested candidates are encouraged to apply or contact EPM for further details.
