Senior Regulatory Affairs Specialist, Medical Devices (Ha Noi)

MAIN RESPONSIBILITIES
• 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

13-month salary & performance bonus
,#Premium Healthcare
,#Training & Development

Regulatory Management, Regulatory Affair