Principal International Regulatory Product Specialist - Diabetes Care (on-site)
Core
Ensure efficient and compliant business processes and environment for the regulatory department, focusing on diabetes care products and glucose monitoring technology.
Role type
Principal International Regulatory Product Specialist
Builds
Regulatory compliant product dossiers, technical documentation, labeling, and procedures for diabetes care devices.
Domain
Healthcare / Medical Devices / Diabetes Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submissions (Pharmaceutical, In vitro diagnostic devices, medical devices), 21 CFR 820, ISO 13485, Medical Devices Directive, IVD Directive, horizon scanning, gap assessments, cross-functional project leadership, risk benefit analysis, market access assessment, SOP development, label development, contract review, crisis management, training facilitation
Preferred skills
RAC certification, EU and international medical device/drugs/pharma regulations, IVDR, design controls, Veeva Vault, dashboarding/automation, matrixed business environment experience
Technologies
Excel, PowerPoint, Veeva Vault
Responsibilities
Contribute regulatory input to product and process change plans; coordinate with regional RA to update submission strategies; establish and maintain a structured horizon-scanning log; lead or co-lead cross-functional working sessions; assist in SOP development and review; provide regulatory input to product lifecycle planning; determine market access issues; maintain annual licenses, registrations, and listings; assist with label development and review for compliance; support knowledge sharing by facilitating training.
Seniority
Principal, hands-on IC with department/group-level influence