Senior Regulatory Affairs Specialist
Core
Plan and execute complex global regulatory projects to obtain and maintain regulatory approvals for medical devices in domestic and international markets.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions (510(k), CE Technical Files), product labeling, and compliance documentation for medical devices.
Domain
Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, submission authoring (510(k), CE), compliance assessment, audit participation, project management, stakeholder communication
Preferred skills
None stated
Technologies
None stated
Responsibilities
Determine requirements for product submissions and regulatory filings; monitor regulatory changes; communicate regulatory requirements to internal/external customers; review supporting evidence for compliance; lead multifunctional teams on high-priority projects; participate in product labeling development; manage project timelines and recommend solutions.
Seniority
Senior, hands-on IC