Product Risk Manager

Philips
Suzhou
Full timeFunction: Legal, Risk & ComplianceExperience: 1+ yearsSkills: ["People management","Process improvement","Business-level guidance","Stakeholder communication","Risk mitigation focus"]

Lead a cross-functional product risk management team by overseeing risk management activities across the product lifecycle. Own post-market risk assessments and provide business-level guidance on product safety, collaborating with medical affairs to identify harms and align with applicable regulations and standards. Implement and improve risk assessment methodologies, maintain comprehensive documentation, monitor KPI performance, and guide investigations and recommendations to support informed decisions and proactive risk mitigation.

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FursaFursa
Philips
Philips
2 months ago

Product Risk Manager

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Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 27 days agoStatus: Live

Job Summary

Lead a cross-functional product risk management team by overseeing risk management activities across the product lifecycle. Own post-market risk assessments and provide business-level guidance on product safety, collaborating with medical affairs to identify harms and align with applicable regulations and standards. Implement and improve risk assessment methodologies, maintain comprehensive documentation, monitor KPI performance, and guide investigations and recommendations to support informed decisions and proactive risk mitigation.
Location: Suzhou
Employment Type: Full time
Job Function: Legal, Risk & Compliance
Seniority: Manager level

Key Responsibilities

  • •Manage a cross-functional product development team to create and/or approve risk management deliverables for one complex or multiple simple products throughout the lifecycle.
  • •Account for post-market risk assessments and handle product risk management inquiries, participating in investigations and communicating findings and recommendations to senior risk management.
  • •Develop and implement risk assessment methodologies to identify, evaluate, control, and document potential hazards across product development, deployment, and lifecycle management.
  • •Collaborate with medical affairs to identify harms and align with applicable regulations and standards to mitigate risks and safeguard patient, user, and consumer safety.
  • •Monitor KPI performance and regulatory/standard requirements, implementing measures to ensure compliance and driving process improvement initiatives for best-in-class practices.

Key Requirements

  • •Bachelor’s or Master’s degree in Medical Sciences, Engineering, Life or Physical Science, Computer Science/Software development, or equivalent.
  • •Minimum 2 years of experience with a Bachelor’s, or minimum 1 year of experience with a Master’s in areas such as Medical Device Product Development, Post Market Surveillance, Quality Engineering, or equivalent.
  • •Experience using post-market surveillance mechanisms and health/safety monitoring practices to support product safety decisions.
  • •Knowledge of quality management systems (QMS) and quality risk management approaches, including CAPA methodologies.
  • •Ability to manage junior team members and ensure adherence to product risk management practices and documentation requirements.
Experience:1+ yearsMedical device product developmentPost market surveillanceQuality engineeringQuality risk managementMedical affairs
Education:
Skills:People managementProcess improvementBusiness-level guidanceStakeholder communicationRisk mitigation focus

Company Brief

Philips
Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Amsterdam, Netherlands
Founded: 1891
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn