Medical Device Assessors

Job Description: Medical Device Assessor & Lead Auditor - Non-Active Devices

Location: Remote / Hybrid (Flexible)

Employment Type: Contract / Permanent

Industry: Medical Devices, Regulatory Affairs, Notified Body

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.

Desirable Skills:

• Expertise in sterile medical devices, biomaterials, and tissue engineering.
• Familiarity with international regulatory frameworks (FDA 21 CFR 820, TGA, MHRA, NMPA, Health Canada).
• Strong training and presentation skills for internal and external stakeholders.

Why Join?

• Work with an experienced regulatory team during a crucial transitional period.
• Contribute to the certification and compliance of cutting-edge non-active medical devices.
• Flexible working arrangements with options for contract or permanent employment.

If you are an experienced Medical Device Assessor or Lead Auditor specializing in non-active devices, this role offers an opportunity to apply your expertise in a critical regulatory environment.

Interested candidates are encouraged to apply or contact EPM for further details.

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