Product Safety Risk Management Specialist jobs in United States
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Philips · 1 day ago

Product Safety Risk Management Specialist

Philips is a health technology company dedicated to improving access to quality healthcare. They are seeking a Product Safety Risk Management Specialist who will assist in developing and documenting the risk management process, prepare reports, and evaluate potential risks associated with products throughout their lifecycle.

B2BConsumer ElectronicsElectronicsLightingWellness
badNo H1BnoteU.S. Citizen Onlynote

Responsibilities

Provides support to the Central Risk Management Team by actively participating in the updates and ongoing maintenance of the Central Philips Risk Management process, ensuring that all risk management procedures are current, effective, and aligned with organizational standards
Prepares and compiles reports and presentations regarding product risk management activities and documents clear communication of findings and recommendations
Performs routine 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
Utilizes tools and software to track, analyze, and evaluate product risks, ensuring effective monitoring and assessment of potential issues to enhance product safety and compliance
Maintains comprehensive and meticulously organized documentation and records related to product risk management compliance, ensuring that all relevant data, procedures, and standards are accurately captured and readily accessible
Compiles post-market data for senior risk manager for the rapid identification of emerging risks and trends, providing invaluable insights and a comprehensive understanding of the evolving landscape to healthcare professionals, regulatory agencies, and stakeholders

Qualification

ISO 14971Medical device regulationsRisk managementProduct lifecycle managementSoftware developmentAnalytical skillsCommunication skillsTeam collaboration

Required

Bachelor's Degree/ Vocational Education in Medical Sciences, Engineering, Life or Physical Sciences, Computer Science/Software development or equivalent
Bachelor's Degree OR Vocational Education with 4+ years of technical experience in Medical Safety, Product Development, Post Market Surveillance, Quality Engineering or equivalent
Prefer hands-on experience to lead and execute risk management activities throughout the product lifecycle
In-depth knowledge of ISO 14971 and global medical device regulatory requirements (FDA, MDR, etc.)
Prefer a strong understanding of medical device products with hands-on experience in software development and the lifecycle management of Software as a Medical Device (SaMD)
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation

Benefits

Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement

Company

Philips is a technology company that operates in various fields, including healthcare, consumer electronics, lighting, and home appliances.

Funding

Current Stage
Public Company
Total Funding
$4.23B
Key Investors
EXOR N.V.Bill & Melinda Gates FoundationInnovative Health Initiative
2025-03-19Post Ipo Equity
2024-05-23Post Ipo Debt· $756.82M
2023-11-07Grant· $44.6M

Leadership Team

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Ed Crawford
CEO Philips Lighting Company NA
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Reema Poddar
President & CEO - Diagnostic & Pathway Informatics Business
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Company data provided by crunchbase