Product Risk Management Specialist
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Job Summary
Job Title
Product Risk Management SpecialistJob 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
Youre 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.
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-
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
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 companys facilities.
Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers 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 wont 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.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If youre 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 here.
Required Experience:
IC
Key Skills
- Sales Experience
- Marketing
- Customer Service
- Communication skills
- Military Experience
- Retail Sales
- Product Demos
- Customer Support
- Product Management
- Product Development
- Unity
- Microscopy
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
