Product Risk Management Specialist
The Product Risk Management Specialist is responsible for contributing expertise in the development and deployment of the central Philips product safety risk management process, enhancing risk management practices and identifying and managing continuous improvements and innovations in risk management. The role will conduct comprehensive risk assessments, analyzing post market data and drive continuous improvement and innovation within the business unit. The role serves as a fully qualified, career-oriented, journey-level position in risk management and contributes advanced knowledge to assess, identify mitigations and ensure regulatory compliance. The role conducts thorough risk assessments and participates in teams developing mitigation strategies to ensure product safety and quality. The role works with limited oversight from senior risk managers
you're the right fit if: (4 x bullets max)
1. Experience- 10+ years of experience in Risk Management, QMS, ISP 13485, prefer from Medtech indsutry
2. Skills-
1. Experience- 10+ years of experience in Risk Management, QMS, ISP 13485, prefer from Medtech indsutry
2. Skills-
- Ensures the adherence of Philips central product safety risk management process to relevant regulations, standards, and organizational protocols, while utilizing tools and software for tracking and analyzing product risks to maintain compliance and effectively manage risk.
- Contributes to the central risk management community of practice, partners with peers in the businesses to enhance risk management methodologies and practices across the organization identified challenges with product safety risk management in product development and post-market.
- Specializes in ARIS design, contributes knowledge to streamline and optimize business processes within the realm of product safety risk management.
Conducts comprehensive risk assessments, detailed analysis, and assists in identifying effective mitigation strategies, safeguarding the patient, user and consumer safety when assigned to assist a business. - Reviews and analyzes reports and presentations on product safety risk management activities, facilitates clear communication of findings and recommendations and scrutinizes comprehensive documentation and records related to product risk management.
- Analyzes post market data to identify emerging product safety risks and trends, contributes to the development of risk mitigation efforts for product risk management to ensure patient, user and consumer safety when working with a business.
- Works with limited oversight from senior risk manager and serves as a fully qualified, career-oriented, journey-level position interested in product risk management, possesses advanced knowledge necessary to contribute to risk assessment, mitigation, and regulatory compliance within the organization.
- Utilizes an advanced understanding of relevant global medical device and healthcare regulations, requirements and standards and executes task related to product risk management, ensuring compliance and fostering safety and quality in all aspects of the process.
- Performs low-complexity evaluations to identify and assess potential risks associated with products at every stage of their lifecycle, ensuring that all possible risk factors are thoroughly examined and addressed.
- Reviews tools and software to track, analyze, and evaluate product risks, ensuring effective monitoring and assessment of potential issues to enhance product safety and compliance.
3. Education- Bachelors/ Masters Degree in Medical Sciences, Engineering, Life or Physical Science, Computer Science/Software development or equivalent.
4. Anything else-
4. Anything else-
Post-Market Surveillance Mechanisms
Health and Safety Monitoring
Quality Management Systems (QMS)
Quality Specifications
Data Analysis & Interpretation
Regulatory Requirements
Technical Documentation
CAPA Methodologies
Continuous Improvement
KPI Management
Quality Risk Management
Reliability Engineering
Product Risk Management
Business Acumen
Health and Safety Monitoring
Quality Management Systems (QMS)
Quality Specifications
Data Analysis & Interpretation
Regulatory Requirements
Technical Documentation
CAPA Methodologies
Continuous Improvement
KPI Management
Quality Risk Management
Reliability Engineering
Product Risk Management
Business Acumen
