Regulatory Affairs Coordinator II
Core
Coordinates regulatory change management, prepares critical regulatory documentation (registrations, STEDs, dossiers), and serves as a liaison for external regulatory data requests.
Role type
Regulatory Affairs Coordinator
Builds
Regulatory documentation and compliance systems for medical technology products
Domain
Medical Technology / Regulatory Affairs
Required skills
Regulatory change management, FDA documentation, SOP/WI updates, EDMS administration, data compilation
Preferred skills
Medical Device Quality Systems, Good Documentation Practices, Notary Public
Technologies
Microsoft Word, Access, Excel, Outlook
Responsibilities
Evaluate and compile regulatory change requests, prepare registration dossiers and technical documentation, respond to external customer data requests, update Standard Operating Procedures, manage departmental administrative functions
Seniority
Entry-level to Junior (1-3 years experience)
