INTRNATL REGULATORY SPECIALIST
Core
Drafts, submits, and gains approval of product registrations and submissions to international regulatory agencies for medical devices.
Role type
International Regulatory Specialist
Builds
Marketing clearance and regulatory filings for orthopedic medical devices globally
Domain
Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
International registration requirements knowledge, regulatory submissions preparation, manufacturing change oversight, labeling review, SOP development, compliance monitoring
Preferred skills
Orthopedic device experience, EMEA/Japan/Brazil market knowledge, product development experience
Technologies
Microsoft Office (Word, Excel, PowerPoint, Teams)
Responsibilities
Prepare and review international Regulatory submissions including CE technical files, obtain timely marketing clearance for products outside the US, oversee regulatory changes in manufacturing facilities and processes, coordinate product labeling for international markets, maintain approved regulatory files and amendments, review design changes and technical files, file Certificates to Foreign Governments with FDA, develop Regulatory SOPs
Seniority
Mid-level, hands-on IC