Role Summary
GRA Device Associate within the Global Regulatory Affairs (GRA) Device Digital and Diagnostic team, supporting global regulatory strategies for medical devices, combination products, digital health and in vitro diagnostic (IVD) products across the Sanofi portfolio. Location: Cambridge, MA; Morristown, NJ; Washington DC. The role involves collaborating with cross-functional teams to navigate regulatory landscapes, influence product approvals, and interact with health authorities worldwide. 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 Identifies IVD regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT Identify issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed Support global filing and lifecycle management activities for device submissions and device aspects of medicinal product submissions Liaises with device, clinical, manufacturing, commercial, and other internal business 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 Supports operational and compliance activities for assigned deliverables, develops and executes 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
Experience: 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 Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes Technical Knowledge: Understanding of clinical development of medicinal products, IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets; working knowledge of global IVD regulations (FDA IDE/PMA, EU IVDR), regulatory documentation, ISO standards (13485, 15189), CLIA accreditation, lab-developed tests, and clinical performance studies; ability to synthesize and analyze data from multiple sources Collaboration Skills: Ability to work effectively in a matrix environment with R&D, Device, Manufacturing, and Quality teams; strong leadership, influencing and negotiation skills Soft Skills: Strategic thinking, initiative, change-agent leadership and risk assessment proficiency; ability to align overall business objectives with project strategies Education: Bachelor's degree in a scientific or engineering discipline; graduate degree preferred Communication: Strong written and verbal communication and influencing skills, with fluency in English Adaptability: Ability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site) Skills
Regulatory strategy development for medical devices and IVDs Preparation and review of regulatory submissions and design control deliverables Health Authority negotiations and interactions Risk assessment and regulatory risk mitigation for IVDs Cross-functional collaboration with R&D, Device, Manufacturing and Quality Knowledge of global IVD regulations (FDA IDE/PMA, EU IVDR) and ISO standards (13485, 15189); CLIA and lab-developed tests Data synthesis and regulatory impact assessment for proposed product changes Clear written and verbal communication in English Education
Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred. Additional Requirements
Hybrid work environment with approximately 60% on-site presence
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GRA Device Associate within the Global Regulatory Affairs (GRA) Device Digital and Diagnostic team, supporting global regulatory strategies for medical devices, combination products, digital health and in vitro diagnostic (IVD) products across the Sanofi portfolio. Location: Cambridge, MA; Morristown, NJ; Washington DC. The role involves collaborating with cross-functional teams to navigate regulatory landscapes, influence product approvals, and interact with health authorities worldwide. 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 Identifies IVD regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT Identify issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed Support global filing and lifecycle management activities for device submissions and device aspects of medicinal product submissions Liaises with device, clinical, manufacturing, commercial, and other internal business 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 Supports operational and compliance activities for assigned deliverables, develops and executes 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
Experience: 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 Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes Technical Knowledge: Understanding of clinical development of medicinal products, IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets; working knowledge of global IVD regulations (FDA IDE/PMA, EU IVDR), regulatory documentation, ISO standards (13485, 15189), CLIA accreditation, lab-developed tests, and clinical performance studies; ability to synthesize and analyze data from multiple sources Collaboration Skills: Ability to work effectively in a matrix environment with R&D, Device, Manufacturing, and Quality teams; strong leadership, influencing and negotiation skills Soft Skills: Strategic thinking, initiative, change-agent leadership and risk assessment proficiency; ability to align overall business objectives with project strategies Education: Bachelor's degree in a scientific or engineering discipline; graduate degree preferred Communication: Strong written and verbal communication and influencing skills, with fluency in English Adaptability: Ability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site) Skills
Regulatory strategy development for medical devices and IVDs Preparation and review of regulatory submissions and design control deliverables Health Authority negotiations and interactions Risk assessment and regulatory risk mitigation for IVDs Cross-functional collaboration with R&D, Device, Manufacturing and Quality Knowledge of global IVD regulations (FDA IDE/PMA, EU IVDR) and ISO standards (13485, 15189); CLIA and lab-developed tests Data synthesis and regulatory impact assessment for proposed product changes Clear written and verbal communication in English Education
Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred. Additional Requirements
Hybrid work environment with approximately 60% on-site presence
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