International Regulatory Specialist
Core
Drafting, submitting, and gaining approval of product registrations and submissions to international regulatory agencies for medical devices.
Role type
International Regulatory Specialist
Builds
Marketing clearance for medical devices in international markets
Domain
Medical devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory submission preparation, CE technical file development, FDA compliance, ISO standards conformance, regulatory gap assessment, technical documentation review, manufacturing change oversight, SOP development
Preferred skills
EU MDR submission experience, Letters to File preparation, Regulatory Release Memo creation, 510(k) regulatory analysis
Technologies
CE technical files, FDA submissions, ISO standards
Responsibilities
Develop regulatory submissions with cross-functional teams, obtain timely marketing clearance parallel to US submissions, oversee manufacturing changes for international compliance, coordinate product labeling for non-US markets, review design changes and technical files, prepare certificates for foreign governments, develop regulatory SOPs, perform regulatory gap assessments
Seniority
Mid-level, hands-on IC