Join one of the leading Notified Bodies in the medical device industry and contribute to ensuring the safety and efficacy of medical devices worldwide. Our organization is committed to upholding the highest standards of regulatory compliance and quality assurance to safeguard patients and healthcare professionals.
Position Overview: We are seeking a highly skilled and experienced Medical Device Auditor to join our dynamic team. The successful candidate will play a crucial role in assessing the compliance of medical device manufacturers with regulatory requirements and international standards. This position offers an exciting opportunity to work with cutting-edge medical technologies and collaborate with industry leaders in ensuring the safety and quality of medical devices.
Key Responsibilities:
- Conduct audits of medical device manufacturers' quality management systems to ensure compliance with relevant regulations and standards, including ISO 13485, MDSAP, and EU Medical Device Regulation (MDR).
- Evaluate the design, development, manufacturing, and post-market surveillance processes of medical devices to assess conformity with applicable regulatory requirements.
- Review documentation, including technical files, design dossiers, and regulatory submissions, to verify completeness, accuracy, and compliance with relevant standards and regulations.
- Identify non-conformities and areas for improvement during audits and provide comprehensive recommendations to manufacturers for corrective and preventive actions.
Qualifications:
- Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
- Minimum of 4 years of experience in medical device auditing, quality management, or regulatory affairs, preferably within a Notified Body or equivalent regulatory agency.
- In-depth knowledge of medical device regulations and standards, including ISO 13485, MDSAP, MDR, and FDA regulations.
- Professional certifications such as Lead Auditor Certification (e.g., ISO 13485 Lead Auditor) or Certified Quality Auditor (CQA) preferred.
