GRA Device Associate

Role Summary

The GRA Device Associate supports global regulatory strategies for in-vitro diagnostic technologies within the Sanofi portfolio, collaborating with cross-functional teams to navigate regulatory landscapes and influence product approvals. The role involves preparing regulatory submissions, managing compliance, and interacting with health authorities. Located in Cambridge, MA / Morristown, NJ / Washington DC, and operating in a hybrid environment.

Responsibilities

• Partner with the Device Regulatory Lead on assigned projects
• Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
• Contribute to and execute innovative and sustainable medical device regulatory strategies covering IVD elements
• Contribute to device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
• Identify IVD regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT
• Identify issues and opportunities that impact submissions timelines; ensure appropriate communication, resolution and/or escalation as needed
• Support global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
• Liaise with device, clinical, manufacturing, commercial, and other internal partners to enable successful regulatory outcomes
• Prepare and review design control deliverables
• Contribute to product development and lifecycle management planning; provide regulatory impact assessments for proposed product changes
• May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed
• Support operational and compliance activities for assigned deliverables; develop, execute regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management
• Contribute to internal regulatory processes and procedures for IVD

Qualifications

• Required: 6+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 3+ years of relevant IVD regulatory experience and contributions to regulatory filings; experience responding to Health Authority questions
• Required: Experience preparing regulatory documentation and familiarity with standard submission processes
• Required: Technical knowledge of clinical development, IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets; working knowledge of global IVD regulations (US FDA IDE/PMAs, EU IVDR), technical documentation, ISO 13485/15189, CLIA, lab developed tests, and clinical performance studies; ability to synthesize data from multiple sources
• Required: Collaboration skills to work effectively in a matrix environment with R&D, Device, Manufacturing, and Quality teams; strong leadership, influencing, and negotiation skills
• Required: Strategic thinking, initiative, change leadership and risk assessment proficiency; ability to align business objectives with project strategies
• Required: Education – Bachelor's degree in a scientific or engineering discipline; Graduate degree preferred
• Required: Strong written and verbal communication and influencing skills; fluent in English
• Required: Adaptability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site)

Skills

• Regulatory strategy development for medical devices/IVDs
• Health Authority engagement and regulatory submissions
• Risk assessment and mitigation for regulatory programs
• Cross-functional collaboration across R&D, Device, Manufacturing, and Quality
• Regulatory documentation and technical writing
• Strategic negotiation and influence with authorities

Education

• Bachelor's degree in a scientific or engineering discipline
• Graduate degree preferred

Additional Requirements

• Hybrid work environment with ~60% on-site requirement