Principal International Regulatory Product Specialist - Diabetes Care (on-site)
Core
Principal International Regulatory Product Specialist ensuring efficient and compliant business processes for diabetes care products and sensing technology.
Role type
Senior IC regulatory operations specialist
Builds
Global regulatory submissions, dossiers, and compliance strategies for medical devices and diagnostics
Domain
Healthcare / Medical Devices / Diabetes Care
Required skills
regulatory submissions, gap assessments, horizon scanning, cross-functional project leadership, SOP development, risk-benefit analysis, market access strategy, license maintenance, post-marketing compliance, contract review, label development, crisis management, training facilitation
Preferred skills
RAC certification, EU/international regulations expertise, design controls, Veeva Vault, dashboarding/automation, matrixed environment experience
Technologies
Excel, PowerPoint, Veeva Vault
Responsibilities
Contribute regulatory input to product change plans, coordinate regional RA strategies, establish horizon-scanning logs, lead cross-functional working sessions, assist in SOP development, provide input to product lifecycle planning, assess regulatory history and market access issues, monitor changing regulations, maintain annual licenses, assist with recalls and communications, support knowledge sharing and training
Seniority
Principal, hands-on IC with department-level influence