Lead Specialist Regulatory Affairs
Core
Prepare high-quality regulatory documentation, support submissions, and ensure compliance for Maternal Infant Care products across the global product lifecycle.
Role type
Lead Specialist Regulatory Affairs (early career professional)
Builds
Global registration plans, submissions, and compliance deliverables for medical devices
Domain
Medical technology / Regulatory Affairs
Required skills
Regulatory documentation preparation, global registration planning, submission support, compliance monitoring, technical document writing, regulatory research, risk identification, project management
Preferred skills
Quality Assurance experience, product design or engineering background, manufacturing knowledge, clinical experience
Technologies
None stated
Responsibilities
Apply country- and region-specific regulations to prepare documentation and support submissions; monitor regulatory changes and assess impact on products; collaborate with cross-functional teams including Quality Assurance and Engineering; communicate regulatory strategy and risks to leadership
Seniority
Mid-level, limited direct oversight