Regulatory Affairs Specialist
Core
Develop global regulatory strategies for software medical devices and manage submissions/approvals in the US, Europe, and Canada.
Role type
Regulatory Affairs Specialist (Software Medical Devices)
Builds
Regulatory submissions and approvals for software medical devices
Domain
Healthcare / Medical Devices / Software
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission preparation, global regulatory strategy, audit support, compliance with ISO 13485/IEC 62304/ISO 14971, MDD/MDR familiarity, cross-functional collaboration
Preferred skills
Regulatory Affairs Certification
Technologies
Microsoft Office, Copilot
Responsibilities
Develop global regulatory strategies, prepare and manage regulatory submissions, represent RA on cross-functional teams, coordinate submission activities, communicate approval status to business, maintain regulatory filings, support internal/external audits
Seniority
Mid-level (3-5 years experience)
