What We Can Offer
Responsible for activities which lead to and maintain regulatory approval to market medical devices in Vietnam and/or any assigned market.
Develops and implements regulatory strategies for earliest possible approvals. Ensures timely preparation and submission of technical/regulatory documents to the authorities for product registration. Builds rapport with regulatory agencies. Anticipates regulatory environment change and actively manages the regulatory intelligence for new policy, regulation and requirements.
Develop registration strategies, prioritizing assignments, implementing regulatory plan and coordinating multiple projects and activities in accordance with latest regulatory requirement and commercial plan.
Manage the regulatory approval or registration of medical devices, license & certificate maintenance to ensure business continuity in Vietnam (and potentially other South East Asia countries) in accordance with applicable local health authorities’ regulations.
Develop and maintain tracking of regulatory status/activity (including prioritization) and ensure the database are kept up to date.
Provide regulatory assessments (e.g. new product development, life-cycle engineering changes/line extensions etc), monitor and manage the necessary regulatory submissions.
Monitor and timely reporting on changes or upcoming changes to medical device laws & regulations affecting registration, distribution and sale & marketing of Abbott products
Cultivation of professional working relationships with local regulatory authorities and local medical device industry association.
Review and approval of A&P materials to ensure compliance with local regulations.
Serve as internal consultant on regulatory requirements such as recalls, advertising and promotional activities or field actions.
Works with internal stakeholders on projects to ensure products meet country import requirements, e.g. labeling
Manages the responsible operational budget effectively
Train other RA team members on Vietnam regulatory requirements as required.
OTHER FUNCTIONS AND RESPONSIBILITIES
Execute the job responsibilities according to applicable standard operating procedures
Perform other related functions and responsibilities assigned by supervisor
Bachelor degree in relevant major.
Minimum 2 years RA experience.
Experience gained in multinational companies, especially in Medical devices is a plus