Regulatory Affairs Manager – APAC - Diabetes Care (on-site)
Core
Manage regulatory strategies and team for Diabetes Care products across the APAC region, ensuring compliance with local legislation and supporting product registration.
Role type
Senior Regulatory Affairs Manager (Medical Devices/IVD)
Builds
Global regulatory strategies and compliant product registrations for Diabetes Care portfolio
Domain
Healthcare / Medical Devices / Diabetes Care
Deliverable
client delivery
Required skills
Regulatory strategy, team management, cross-functional collaboration, regulatory submission compilation, design change evaluation, post-marketing compliance, audit support, labeling review, APAC regulatory landscape knowledge
Preferred skills
Supervisory experience, scientific writing, ISO/EN standards knowledge, RAC certification
Technologies
Medical device/IVD regulatory frameworks
Responsibilities
Manage a team of regulatory specialists; Develop organizational policy and procedures for regulatory affairs; Represent Regulatory Affairs on cross-functional project teams; Compile, prepare, and review medical device or IVD submissions to regulatory agencies; Evaluate proposed design and manufacturing changes for regulatory impact; Ensure compliance with product post-marketing approval requirements; Review product labeling and promotional materials for compliance; Provide regulatory support for internal and external audits.
Seniority
Senior, hands-on IC with team leadership
