Qualifications: Bachelor's or Master's degree in Engineering, Biomedical, Life Sciences, or a related field. Minimum of 12 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. Show more Show less

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Risk Management Specialist