GRA Device Associate - Medical Devices and Combination Products (Senior Manager)

About the role

The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health and in-vitro diagnostic (IVD) products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team is accountable for developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post-marketing stages. The team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others.

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 stand-alone medical devices and device part of combination products elements.
• Contribute to device Health Authority interactions plan, support device related and cross-functional health authority interactions.
• Identifies medical devices 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/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 medical devices Health Authorities for projects/products in their remit, as needed.
• Serves as a subject matter expert on medical device regulations and provides regulatory guidance to cross-functional teams.
• Participates in regulatory strategy development and implementation for medical devices and combination products.
• Collaborates with cross-functional teams to develop and implement regulatory strategies for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including drafting and reviewing regulatory documents, conducting risk assessments, and interacting with regulatory authorities.
• Ensures compliance with regulatory requirements and guidelines for medical devices and combination products.
• Manages regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Provides regulatory guidance and support to cross-functional teams, including clinical development, manufacturing, and quality teams, to ensure regulatory compliance and facilitate product development and commercialization.
• Participates in regulatory affairs activities for medical devices and combination products, including drafting and reviewing regulatory documents, conducting risk assessments, and interacting with regulatory authorities.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Participates in regulatory affairs activities for medical devices and combination products, including drafting and reviewing regulatory documents, conducting risk assessments, and interacting with regulatory authorities.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and combination products, including coordinating with regulatory authorities, preparing and submitting regulatory documents, and monitoring regulatory developments.
• Contributes to the development and maintenance of regulatory processes and procedures for medical devices and combination products.
• Supports regulatory affairs activities for medical devices and