THE POSITION:
The Regulatory Affairs Specialist I is responsible for supporting the Specialty Diagnostics Group (SDG) Regulatory Affairs (RA) Team for the registration of In- Vitro Diagnostic (IVD) medical devices in Vietnam. The role requires strong communication to work with internal stakeholders (project leads, commercial, divisional RA) and external parties (health authorities and local distributors) to execute tasks effectively. This role calls for a strong drive to own your results by ensuring timely pre- market submission to enable business and maintain databases for traceability. Key qualities include a compliance mindset, commitment to deliver high quality work and being systematic to navigate and manage multiple registrations.
Job responsibilities:
Responsible for the regulatory activities for the product registration including:
Compile, review and ensure the accuracy of all registration documentation to facilitate successful submissions.
Accurately update and maintain assigned sections of internal regulatory trackers and databases.
Complete additional administrative and regulatory tasks as assigned by the supervising manager.
Prepare and submit registration dossiers to the competent authority and proactively manage the follow- up and secure timely approval.
Collaborate with divisional RA to identify, request, review and obtain the documentation required for registration dossiers.
Provide regular updates on registration status to the supervising manager to support communication with internal stakeholders i.e. project leads, divisional RA and local distributors.
Prepare responses to the competent authority queries on registration submissions for review by supervising manager.
Requirements:
Education and qualification
Minimum 2 years of medical device regulatory experience (IVD experience is preferred).
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry or Health- related discipline.
Essential Skills and Abilities
Meticulous, strong learning agility, ability to work independently with initial guidance from senior staff.
Ability to work effectively and collaboratively, across cultures and functions.
Having experience of working with Vietnamese Ministry of Health (Infrastructure and Medical Device Administration) is advantageous.
Systematic in handling multiple registration work.
Possess results- oriented mindset, good analytical skills, and attention to details.
Excellent communication, written, verbal and presentation skills, particularly in regulatory affair applications in Vietnamese and English.
Able to work under pressure and flexible working hours based on business requirements.
