Product Risk Management Specialist

Job Description

Job title:
Product Risk Management Specialist

Your role:
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
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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-

• 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.
  u2022 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- Bachelor's/ Master's Degree in Medical Sciences, Engineering, Life or Physical Science, Computer Science/Software development or equivalent.
4. Anything else-

u2022 Post-Market Surveillance Mechanisms
u2022 Health and Safety Monitoring
u2022 Quality Management Systems (QMS)
u2022 Quality Specifications
u2022 Data Analysis & Interpretation
u2022 Regulatory Requirements
u2022 Technical Documentation
u2022 CAPA Methodologies
u2022 Continuous Improvement
u2022 KPI Management
u2022 Quality Risk Management
u2022 Reliability Engineering
u2022 Product Risk Management
u2022 Business Acumen

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 companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If youu2019re 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. Learn more about our culture of impact with care .