Regulatory Affairs Specialist
Core
Plan and execute global regulatory activities to obtain and maintain regulatory approvals for medical devices across new launch markets and post-market changes.
Role type
Regulatory Affairs Specialist
Builds
Regulatory submissions and filings for medical device clearance/approval
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory strategy development, FDA regulations knowledge, compliance evaluation, documentation review, regulatory filing management, product labeling substantiation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Determine requirements for product submissions and regulatory filings, communicate regulatory requirements to internal/external customers, review documentation for compliance, collaborate on regulatory filings and respond to regulator questions, participate in product labeling development, present project objectives and act as subject matter expert
Seniority
Mid-level, individual contributor