Qualifications:
- Bachelor's or Master's degree in Engineering, Biomedical, Life Sciences, or a related field.
- Minimum of 6 years of experience in risk management within the medical device industry .
- In-depth knowledge of ISO 14971 and global regulatory requirements (FDA, EU MDR/IVDR, TGA, etc.).
- Strong background in risk analysis tools: FMEA, FTA, HACCP, etc.
- Experience with Class II/III medical devices preferred.
- Excellent problem-solving, analytical, and decision-making skills.
- Strong communication and leadership skills.
- Experience working in cross-functional, global teams.
- Certifications such as RAC, CQE, or Six Sigma are a plus.