Philips is hiring an experienced Product Risk Manager at their Bangalore location
SANDEEP KUMAR | May 11, 2023 |
Vacancy for Science, Engineering Graduates at Philips
Philips is hiring an experienced Product Risk Manager at their Bangalore location. This role Ensures the Policy for Establishing Safety Risk Acceptability for the product is created, approved, and maintained by top management.
The complete details of this job are as follows:
Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development
Monitors and reports on the product’s safety risk management performance in the field and ensures deliverables are updated as needed
Ensures the appropriate risk assessments are performed when triggers are met
Defend Risk Management and design quality activities during external and internal audits
Perform periodic reviews of Risk Management Files and ensure those are performed according to schedule
Evaluate process and product changes for their impact to the current Risk Management Files.
Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files
Work with global experts to drive the common practice and best practice across sites for risk management, design regulations compliance and business requirements
Coordinates with a cross functional team including Engineering and Medical Affairs in the creation and maintenance of the deliverables listed above
Bachelor’s degree, Engineering or Science discipline preferred or equivalent work experience
3+ years working experience in a regulated industry
3+ years working experience in product development or post-market surveillance, system engineering experience – an advantage
Experience in creating risk management deliverables
Knowledge of ISO 14971 and product specific regulations and standards – an advantage
Clinical knowledge – an advantage
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