Sanofi
Healthcare
DeviceQualityEngineer-DeviceRiskManagementandSurveillanceExcellence
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“Device Quality Engineer - Device Risk Management and Surveillance Excellence at Sanofi. Skills: Device Risk Management, Post-Market Surveillance, Regulatory Compliance, ISO 14971. Lead Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes across Sanofi as the global process owner. Ensure SOPs align with applicable regulations and industry standards while driving continuous improvement initiatives”
What You'll Achieve.
Lead critical global processes for patient safety and regulatory compliance; Ensure Medical Devices and Drug-Device Combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle; Deliver expert quality support for risk management and post-market surveillance activities across the development pipeline and post-launch lifecycle management; Ensure expert evaluations on patient safety and compliance matters
Industry & Context.
Analyze post-market data to identify trends, multi-site impacts, and implement corrective actions
What They're Looking For.
Must Have
BS degree in Engineering, Business, Life Sciences or related science discipline., 5+ years of medical device industry experience., 3+ years of relevant experience in in Risk Management and Post-Market Surveillance for medical devices and/or drug-device combination products., Ability to collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business knowledge in problem solving, deep knowledge of ISO 14971., Knowledge of ISO 13485, MDR (2017/745) and 21 CFR 820, Mandatory English management for Business (written and oral)
Nice to Have
MS degree is a plus, Experience in complaint management a plus, French or German are a plus.
What You'll Do.
Lead Device Risk Management
and Post-Market Surveillance processes across Sanofi as the global process owner
Ensure SOPs align with applicable regulations and industry standards while driving continuous improvement initiatives
Analyze post-market data to identify trends
and implement corrective actions
Ensure Device Risk Management Files accurately reflect current product risks and remain updated throughout the product lifecycle
Provide guidance on harmonized risk management approaches aligned with ISO 14971 across all development and lifecycle management programs
comprehensive training programs and mentor colleagues on process execution
and risk management methodologies
Ensure project teams utilize appropriate risk analysis tools (FMEAs
PHA) and facilitate dFMEA moderation sessions
Author and maintain post market surveillance deliverables throughout the product lifecycle
Support Design Controls implementation for new product development and design changes
including Design History File maintenance
How You'll Work.
Team & Collaboration
Collaborating with cross-functional teams and external stakeholders; Partner with quality, compliance, development, and manufacturing teams to ensure transparency, coordination, and patient safety actions; Ability to collaborate effectively with peers, stakeholders, and partners across the organization
Communication Scope
Mandatory English management for Business (written and oral)
Full Job Description
**Job Title** : Device Quality Engineer - Device Risk Management and Surveillance Excellence * Location: Cambridge, MA **About the Job** As Device Quality Engineer - Device Risk Management and Surveillance Excellence within our Global Device and Packaging Unit (GDPU), you will lead critical global processes for patient safety and regulatory compliance. You are accountable for maintaining and continuously improving Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes, ensuring Medical Devices and Drug-Device Combination products comply with ISO 14971, MDR, and other relevant regulations throughout their lifecycle. You will deliver expert quality support for risk management and post-market surveillance activities across the development pipeline and post-launch lifecycle management. The role involves collaborating with cross-functional teams and external stakeholders to ensure expert evaluations on patient safety and compliance matters. **About Sanofi:** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. **_Main Responsibilities_** * Lead Device Risk Management, Clinical Evaluation, and Post-Market Surveillance processes across Sanofi as the global process owner * Ensure SOPs align with applicable regulations and industry standards while driving continuous improvement initiatives * Analyze post-market data to identify trends, multi-site impacts, and implement corrective actions * Ensure Device Risk Management Files accurately reflect current product risks and remain updated throughout the product lifecycleProvide guidance on harmonized risk management approaches aligned with ISO 14971 across all development and lifecycle management programs * Develop new tools, comprehensive training prog
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