Regulatory Affairs Specialist
Core
Enable market access for regulated medical devices by preparing submissions, responding to agency actions, and ensuring compliance.
Role type
Regulatory Affairs Engineer
Builds
Regulatory submissions and compliance processes for medical devices
Domain
MedTech / Radiation Therapy
Deliverable
client delivery
Required skills
Regulatory submissions, cross-functional collaboration, audit execution, process documentation, change management, project reporting, problem-solving
Preferred skills
Engineering degree or equivalent, product regulation knowledge, independent work, multicultural environment adaptability
Technologies
Microsoft Office
Responsibilities
Prepare and release regulatory submissions to governing agencies, Collaborate with cross-functional teams to define processes, Authorize documents and forms related to regulatory activities, Plan and execute audits, Issue and update processes and procedures, Provide timely and accurate project reports
Seniority
Individual Contributor