Job Information
Abbott Senior Regulatory Affairs Specialist - Medical Devices in Hanoi, Vietnam
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
EXPERIENCE REQUIRED
• Minimum 2 years RA experience.
• Experience gained in multinational companies, especially in Medical devices is a plus
• Bachelor degree in relevant major
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com