A leading Notified Body is seeking experienced Medical Device and In Vitro Diagnostic (IVD) Product Reviewers / Auditors to join its growing certification and regulatory compliance team. This role is crucial in ensuring that medical devices and IVD products meet the highest safety, quality, and regulatory standards in accordance with EU MDR (2017/745), IVDR (2017/746), ISO 13485, and other relevant regulations.
The successful candidates will be responsible for conducting technical documentation reviews, audits, and assessments for a wide range of medical devices and IVD products. They will play a key role in supporting manufacturers to achieve and maintain compliance with European and international regulatory requirements.
Key Responsibilities:
- Perform technical documentation reviews for medical devices and IVDs, ensuring compliance with EU IVDR, MDR, ISO 13485, and other relevant standards.
- Conduct conformity assessments and audits of manufacturers' quality management systems.
- Evaluate biological, chemical, and clinical performance data to ensure product safety and effectiveness.
- Provide expert guidance to manufacturers on regulatory requirements, risk management, and post-market surveillance obligations.
- Lead onsite and remote audits to assess compliance with applicable regulatory and quality system standards.
- Prepare detailed audit and review reports, clearly outlining findings and recommendations.
- Stay up to date with evolving IVDR, MDR, and global regulatory changes to ensure accurate and informed decision-making.
- Collaborate with internal teams and regulatory bodies to ensure a transparent and consistent certification process.
