Lead Specialist Regulatory Affairs
Core
Supports regulatory activities for assigned products and markets throughout the product lifecycle, including global registration planning, submissions, audits, and compliance deliverables for Maternal Infant Care programs.
Role type
Senior Regulatory Affairs Specialist (Maternal Infant Care)
Builds
Regulatory documentation, submissions, and compliance deliverables for global market access
Domain
Medical technology / Healthcare regulatory affairs
Required skills
Regulatory affairs expertise, knowledge of country/region-specific regulations, technical document writing, regulatory submission management, compliance monitoring, risk assessment, project management
Preferred skills
Science/engineering/health sciences/legal studies degree, experience in Quality Assurance or product design, familiarity with notified body audits
Technologies
Regulatory submission systems, quality management systems
Responsibilities
Apply regulations and internal procedures to prepare regulatory documentation; support global registration planning and submissions; monitor regulatory changes and assess impact; research and analyze technical information for submissions; develop go-to-market strategies based on regulatory constraints; maintain product technical knowledge and compliance status
Seniority
Senior, hands-on IC with limited direct oversight