Regulatory Affairs Manager – APAC - Diabetes Care (on-site)
Core
Manage regulatory strategies and compliance for the Diabetes Care product portfolio across the Asia Pacific (APAC) region, leading a team of specialists and ensuring product registration and post-market compliance.
Role type
Senior Regulatory Affairs Manager (APAC)
Builds
Global regulatory strategies and compliant product registrations for Diabetes Care devices in APAC
Domain
Healthcare / Medical Devices / Diabetes Care
Required skills
Regulatory strategy, team management, cross-functional collaboration, regulatory submissions, compliance auditing, change management, labeling review, post-market surveillance, stakeholder communication
Preferred skills
Supervisory experience, scientific writing, ISO/EN standards knowledge, APAC regulatory landscape expertise, RAC certification
Technologies
Regulatory submission systems, compliance management tools
Responsibilities
Manage a team of regulatory specialists; Develop and advance 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; Provide strategic input on regulatory authority queries; Evaluate design and manufacturing changes for regulatory impact; Oversee processes for maintaining annual licenses, registrations, and listings; 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