Regulatory Affairs Specialist
Core
Ensure global product compliance and adherence to regulatory requirements for IVD devices, supporting submissions and market access.
Role type
Regulatory Affairs Specialist (IVD)
Builds
Regulatory submissions, technical documentation, and compliance strategies for international markets.
Domain
Medical Devices / In Vitro Diagnostics (IVD)
Required skills
IVD regulatory requirements, international submissions (FDA, IVDR, MDSAP), risk assessment, complaint handling, post-market surveillance, SOP development, labeling review, gap analysis, change control, import/export documentation, audit support, eQMS platforms
Preferred skills
Antibody-based diagnostics experience, leadership, project management
Technologies
MasterControl, AssurX, Veeva Vault QMS
Responsibilities
Prepare and submit regulatory documentation for global markets; compile and maintain technical files and GSPRs; partner with R&D and Quality to integrate regulatory requirements; manage recalls, MDR, and post-market reporting; develop regulatory SOPs and training content; review product labeling and promotional materials; support internal and external audits; coordinate with external consultants for international submissions.
Seniority
Mid-level, hands-on IC