Sanofi

Sanofi

Device Quality Engineer - Device Risk Management and Surveillance Excellence

Cambridge, MA

Sponsorship not specifiedDetected 12 days ago
ComplianceProduct ManagementMedical DevicesCollaborationProblem SolvingMentoring

About the role

  • The role involves collaborating with cross-functional teams and external stakeholders to ensure expert evaluations on patient safety and compliance matters.
  • With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
  • Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.

Responsibilities

  • 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 will deliver expert quality support for risk management and post-market surveillance activities across the development pipeline and post-launch lifecycle management.

Requirements

  • BS degree in Engineering, Business, Life Sciences or related science discipline.
  • knowledge in problem solving methodologies
  • deep knowledge of ISO 14971.
  • Knowledge of ISO 13485, MDR (2017/745) and 21 CFR 820

Nice to have

  • Mandatory English management for Business (written and oral) French or German are a plus.
  • MS degree is a plus
  • Experience in complaint management a plus
  • Languages: Mandatory English management for Business (written and oral) French or German are a plus.

Skills

  • ISO 14971 Risk Management
  • Post-Market Surveillance (PMS)
  • FMEA / Risk Analysis Tools
  • Regulatory Compliance (MDR / 21 CFR 820)
  • Design Controls & DHF Management
  • Soft Skills:
  • Cross-functional Collaboration
  • Strategic Thinking
  • Attention to Detail
  • Stakeholder Influence
  • Mentoring & Knowledge Transfer
  • Why choose us?

Compensation

  • All compensation will be determined commensurate with demonstrated experience.

Benefits

  • Employees may be eligible to participate in Company employee benefit programs.
  • Additional benefits information can be found through the LINK.

Visa & Work Authorization

  • ual opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity
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This listing is sourced directly from Sanofi's careers page and normalized into a canonical job model.