GRA Device Lead (Director) - Sanofi : Job Details

Serve as Device Regulatory Lead on assigned project teams (early phase, late stage and marketed products). Develop innovative and sustainable medical device regulatory strategies covering combination products and delivery systems (device elements). Provide regulatory guidance and advice to development teams. Prepare regulatory design control deliverables. Review and approve design control deliverables. Lead and/or support global filing and lifecycle management activities for device aspects of combination product submissions. Contribute to product development planning, including strategies to bridge delivery systems during development and post-approval changes. Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed. Ensure regulatory plans are monitored, progress/variance communicated to Management and any risks are highlighted. Lead and/or support device related health authority interacti...Lead, Director, Device, Regulatory, Healthcare, Product Development, Business Services