Medical Device Risk Specialist

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.