Risk Management Specialist

3 weeks ago


New Delhi, India UST Full time

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 themedical 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.


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