Risk Management 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.