Associate Regulatory Affairs Specialist - 18 months contract
Core
Coordinate regulatory submissions, license renewals, and labeling compliance for medical devices to ensure timely market approvals.
Role type
Associate Regulatory Affairs Specialist (Entry-level IC)
Builds
Regulatory submission packages and compliance documentation for existing approved medical devices.
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission preparation, labeling compliance review, regulatory agency interaction, quality system compliance, global regulatory requirement knowledge
Preferred skills
Medical device industry experience, internship in regulatory affairs
Technologies
Regulatory submission systems, quality management systems
Responsibilities
Direct or perform coordination of document packages for regulatory submissions; compile materials for license renewals and annual registrations; recommend changes for labeling and clinical protocols; monitor tracking/control systems; interact with regulatory agencies at reviewer level; support manufacturing site registration and audits.
Seniority
Entry-level individual contributor, works with close supervision