Staff Regulatory Affairs Specialist (Hybrid)
Core
Guide regulatory activities across product development, product changes, and lifecycle management for emergency care medical devices to ensure compliance and market availability.
Role type
Staff Regulatory Affairs Specialist
Builds
Regulatory strategies, submissions, and compliance frameworks for medical device product portfolios
Domain
Medical Devices / Regulatory Affairs
Required skills
Regulatory submissions, product registration, regulatory strategy, compliance management, stakeholder communication, risk assessment, filing preparation, authority interaction, lifecycle management, classification evaluation
Preferred skills
Class II/III device experience, Software as a Medical Device (SaMD), regulatory strategy development, RAC certification, master's degree
Technologies
None stated
Responsibilities
Support R&D, Marketing, and Manufacturing teams with regulatory assessments of product changes and software updates; Identify regulatory requirements and barriers to market access; Prepare and submit regulatory filings; Communicate with regulatory authorities; Maintain product registrations; Develop procedures and training materials
Seniority
Staff, hands-on IC with strategic guidance