A leading Notified Body is seeking an experienced Medical Device Auditor with expertise in IEC 60601-1 (Electrical Safety) and Medical Device Software to join its growing team. This role is crucial in ensuring that medical electrical equipment and software-driven devices comply with international regulatory and safety standards, including IEC 60601-1, IEC 62304, ISO 13485, MDR (2017/745), and FDA regulations.
The successful candidate will conduct audits, technical file reviews, and conformity assessments for a wide range of medical devices, ensuring manufacturers meet regulatory requirements and safety standards.
Key Responsibilities:
- Conduct audits of medical device manufacturers to assess compliance with ISO 13485, MDR, and IEC 60601-1 standards.
- Perform technical documentation reviews focusing on medical electrical equipment, active devices, and software-based medical devices.
- Assess compliance with IEC 60601-1 (electrical safety, essential performance, EMC), IEC 62304 (medical software lifecycle processes), and IEC 82304-1 (health software).
- Review risk management files (ISO 14971), cybersecurity measures, and software validation for medical device products.
- Provide guidance and expertise to manufacturers on regulatory expectations for electrical safety, software validation, and risk management.
- Prepare audit reports, conformity assessments, and technical evaluations with clear findings and recommendations.
- Stay updated on global regulatory changes, emerging trends in medical device software, and electrical safety requirements.
- Work closely with regulatory bodies, industry experts, and manufacturers to maintain transparency and compliance in certification processes.
