Strategic Risk Manager

6 days ago


Thiruvananthapuram, Kerala, India beBeeRiskManagement Full time ₹ 20,00,000 - ₹ 25,00,000
Risk Management Specialist Job Summary

We are seeking an experienced professional to develop and implement risk management strategies for medical devices. The ideal candidate will possess in-depth knowledge of ISO 14971 and global regulatory requirements, as well as strong background in risk analysis tools.

The successful candidate will analyze and mitigate risks associated with Class II/III medical devices, collaborate with cross-functional teams to ensure compliance with regulatory requirements, and lead risk-based decision-making processes to drive business growth and success.

Key Responsibilities:
  • Develop and implement risk management strategies for medical devices
  • Analyze and mitigate risks associated with Class II/III medical devices
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements
  • Lead risk-based decision-making processes to drive business growth and success
Requirements:

To be considered for this role, you must have a Bachelor's or Master's degree in Engineering, Biomedical, Life Sciences, or a related field, along with minimum 12 years of experience in risk management within the medical device industry. You should also have in-depth knowledge of ISO 14971 and global regulatory requirements (FDA, EU MDR/IVDR, TGA, etc.), and strong background in risk analysis tools: FMEA, FTA, HACCP, etc.

Additionally, you must have experience working in cross-functional, global teams, and be able to communicate effectively with stakeholders.

Benefits:

This role offers the opportunity to work on complex risk management projects and contribute to the success of our organization. You will have the chance to develop your skills and expertise in risk management, and work with a talented team of professionals who share your passion for innovation and excellence.



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