Product Risk Manager

13 Minutes ago • All levels
Risk Management

Job Description

The Product Risk Manager ensures Philips' adherence to product safety risk management processes, regulations, and standards. This role involves tracking and analyzing product risks, contributing to risk management methodologies, and specializing in ARIS design. Responsibilities include conducting comprehensive risk assessments, identifying mitigation strategies, and analyzing post-market data to address emerging safety risks. The manager works with limited oversight, applying advanced knowledge of global medical device regulations to ensure compliance and product safety throughout the lifecycle.
Good To Have:
  • 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
Must Have:
  • Ensures adherence to Philips' central product safety risk management process.
  • Utilizes tools and software for tracking and analyzing product risks.
  • Contributes to the central risk management community of practice.
  • Specializes in ARIS design to optimize business processes.
  • Conducts comprehensive risk assessments and identifies mitigation strategies.
  • Reviews and analyzes reports on product safety risk management activities.
  • Analyzes post-market data to identify emerging product safety risks.
  • Works with limited oversight from senior risk manager.
  • Applies advanced understanding of global medical device and healthcare regulations.
  • Performs low-complexity evaluations of potential product risks.
  • Reviews tools and software for effective monitoring and assessment of product risks.

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Job Responsibilities:

  • 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.

Minimum required Education:

Bachelor's/ Master's Degree in Medical Sciences, Engineering, Life or Physical Science, Computer Science/Software development or equivalent.

Minimum required Experience:

Minimum 2 years of experience with Bachelor's in areas such as Medical Device Product Development, Post Market Surveillance, Quality Engineering or equivalent OR no prior experience required with Master's Degree.

Preferred Skills:

  • 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 company’s facilities.

Field roles are most effectively done outside of the company’s 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 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.

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. Learn more about our culture of impact with care here.

About Us

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

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