Strategist, Regulatory Affairs
Core
Manage, plan, prepare, and deliver electronic and paper-based regulatory documentation to support global medical device product registrations, renewals, and customs tenders.
Role type
Associate Regulatory Affairs Specialist (Medical Devices)
Builds
Global regulatory submissions and documentation packages for medical device clients
Domain
Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulatory affairs, US FDA QSR, ISO 13485, EU MDD/MDR, Good Documentation Practices (GDP), document legalization/notarization/apostille, tracking tools management, document filing and retrieval
Preferred skills
Global medical devices registration process knowledge, Microsoft Office proficiency
Responsibilities
Coordinate preparation and submission of medical device applications; prepare and review regulatory letters and declarations; manage US FDA Certificates to Foreign Government (CFGs) applications; maintain tracking tools for regulatory data; perform document legalization and notarization; assist regions with inquiries using search tools; communicate status of deliverables to internal and external teams; provide support for technical inquiries; participate in meetings to address basic complexity issues