Product Safety and Risk Management Specialist

4 weeks ago


Pune, Maharashtra, India Philips Full time

Job Title: PMS & RM Specialist


Job Description:


We are seeking a highly skilled Product Safety and Risk Management Specialist to join our team at Philips. As a key member of our organization, you will be responsible for managing activities related to product safety surveillance and risk management, ensuring that our medical devices meet the highest standards of quality and safety.


Your Key Responsibilities:



  • Review and analyze data from clinical studies and spontaneous complaints to identify potential safety issues and regulatory reporting requirements.
  • Serve as a liaison between Medical Affairs, Clinical Affairs, Research & Development, and Complaint Handling to ensure seamless communication and collaboration.
  • Develop and maintain Post-Market Surveillance (PMS) and Risk Management (RM) plans for all products, ensuring consistency and compliance with global regulations.
  • Review and prepare reports on aggregate data, providing recommendations for further escalation and improvement.
  • Collaborate with stakeholders to define standard risk acceptability criteria and develop consistent RM plans for all products.
  • Provide oversight and clinical guidance on risk assessments, including post-market risk assessments and health hazard evaluations.

About the Role:


This is an exciting opportunity to join a dynamic team and contribute to the development of safe and effective medical devices. If you have a passion for product safety and risk management, and a strong desire to make a difference in the lives of patients and customers, we encourage you to apply.


Requirements:



  • Bachelor's degree with a minimum of 8 years of experience in product safety and risk management.
  • Working knowledge of global medical device regulations, requirements, and standards, including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and European Medical Device Directive (93/42/EEC).
  • Excellent verbal and written communication skills, with the ability to effectively collaborate with cross-functional teams.
  • Strong analytical skills, with attention to detail and a focus on delivering high-quality results.
  • Fluency in English, both verbal and written.

How We Work Together:


We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.


About Philips:


We are a health technology company that is committed to improving people's lives. We believe that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips.



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