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.