Help streamline and speed our time to market and build quality in at every step. You will be a member of the new product development team that supports the design and development of innovative, new products within the Surgical Innovations business. You can apply advanced technical concepts to complex problems from concept generation through early phase development.
The Regulatory Affairs/Regulatory Affairs Operations Specialist can assist with preparation of U.S. FDA submissions, Design Dossiers for European Union submissions, Technical Files, reviewing design control documents and change requests, and being an active member of design teams representing the regulatory affairs responsibility.
The Regulatory Affairs/Regulatory Affairs Operations Specialist is also responsible for managing international regulatory registrations with the Regional Business Units (RBU), which includes global regulatory strategies and impact assessments, initial registrations, re-registrations and notifications/registrations of changes that may impact the regulatory approvals.
Impact patient outcomes. Come for a job, stay for a career.
Corporate / junior
Goleta , United States