Regulatory Affairs Specialist
Core
Prepare, review, submit, and maintain regulatory documentation for medical device registrations in Vietnam to ensure compliance with local regulations and secure market access.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
Medical device product registrations and market access in Vietnam
Domain
Healthcare / Medical Devices / Vietnam Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory documentation preparation, pre-market and post-market regulatory support, regulatory monitoring, health authority communication, audit support, labeling and promotional material review, regulatory procedure development, database and record management
Preferred skills
Cross-functional collaboration, project management, problem solving, working under pressure, detail-oriented organization
Technologies
Regulatory databases, tracking systems
Responsibilities
Prepare and submit regulatory documentation for medical device registrations in Vietnam; Support pre-market and post-market regulatory activities; Monitor changes in Vietnam regulatory requirements; Maintain communication with local health authorities; Support regulatory inspections and audits; Review labeling and promotional materials for compliance; Develop and update regulatory procedures and documentation
Seniority
Mid-level, hands-on IC
