Principal Regulatory Affairs Specialist – APAC - Diabetes Care (on-site)
Core
Lead strategic planning and regulatory registration for diabetes care products to ensure timely release into the Asia Pacific (APAC) market.
Role type
Principal Regulatory Affairs Specialist (Medical Devices/IVD)
Builds
Product registration and release authorization for diabetes monitoring technologies
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 for medical devices and IVD, knowledge of 21 CFR 820, ISO 13485, EU MDR, EU IVDR, cross-functional coordination, risk management, team leadership, scientific writing
Preferred skills
Master's or Doctorate in technical/medical field, 5+ years regulatory affairs experience, international registration experience (APAC focus), fluency in Chinese, RAC certification
Technologies
ISO 13485, 21 CFR 820, EU MDR, EU IVDR
Responsibilities
Execute product registration and release for APAC geographies, drive strategic engagement with regulatory authorities, coordinate with global and cross-functional teams, develop and refine product release processes, hire and develop staff, evaluate product issues for compliance
Seniority
Principal, strategic lead with hands-on execution