Wipro is seeking an experienced Risk Management Specialist with expertise in medical devices to join our dynamic team. The ideal candidate will have strong knowledge of ISO 14971, risk assessment methodologies, FMEA, hazard analysis, and regulatory compliance for medical devices.
Key Responsibilities:
- Conduct risk management activities for medical devices as per ISO 14971 and other regulatory standards.
- Perform risk assessments, hazard analysis, FMEA (Failure Mode and Effects Analysis), and risk-benefit analysis.
- Ensure compliance with FDA, EU MDR, and other global medical device regulations.
- Collaborate with cross-functional teams (R&D, Quality, Regulatory) to mitigate risks.
- Prepare and maintain risk management files (RMF) and documentation.
- Support post-market surveillance (PMS) and risk management reviews.
- Communicate effectively with stakeholders on risk-related matters.
Required Skills & Qualifications:
- 3-9 years of experience in risk management for medical devices.
- Strong understanding of ISO 14971, IEC 62304, EU MDR, and FDA guidelines.
- Excellent communication skills in English (written & verbal).
- Willingness to work in rotational shifts and relocate to Kolkata, Bhubaneswar, or Pune.
- Ability to work from office and collaborate with global teams.
About Wipro
Wipro Limited (NYSE: WIT) is a leading global IT, consulting, and business process services company. With over 75 years of innovation, Wipro delivers cutting-edge solutions in healthcare, life sciences, and medical devices. Our risk management and regulatory teams ensure compliance and patient safety for medical device manufacturers worldwide.
How to Apply?
Interested candidates meeting the above criteria can share their updated resume to:
📧 Email: sarita.biswas@wipro.comFMEA & Hazard Analysis Jobs in Medical Devices – Life Science Graduates Apply
