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
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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
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