(Senior) Regulatory Affairs Specialist - Medical Device

• Responsible for implementing and managing the regulatory activities of medical devices
following MOH (Ministry of Health) registration guidelines, including new product
submission, renewal submission, and variations
• Maintain data in information systems or databases. Have responsibility in following up &
making new or renewed registration for all company products, following up expiry of
FSC, EC & ISO to update timely & distribution authorization term...)
• Liaising and negotiating with regulatory authorities and providing advice about
regulations to principals and company. Responsible for all communication and follow- up
with the Ministry of Health to ensure a smooth and fast registration process.
• Keep manufacturer on update with any feedback from authorities and deal with facility or
regional team for their support to accelerate approval of Ministry of Health.
• Provide regulatory assessments (e.g. new product development, life- cycle engineering
changes/ line extension etc.), monitor and manage the necessary regulatory
submissions.
• Provide regulatory support in tender submission and corresponding inquiry as required.
Advice and supporting business, marketing and others team in regulatory.
• Ensuring the awareness on obligations to comply with regulatory requirements and other
throughout the establishment and supply chain.
applicable statutory requirements and any decision thereof made by top management
• Keeping up to date with changes in regulatory legislation and guidelines. Monitor and
regulations affecting registration, distribution and sale & marketing team.
timely reporting on changes or upcoming changes to medical device laws and
• Review and approval of relevant documents/materials to ensure compliance with local
regulations. Outlining requirements for labelling, storage and packaging, and approving
information leaflets and labels.
• Any other duties and responsibilities as and when assigned by Line Manager

• Good communication in Vietnamese and English
• Displaying strong detailed knowledge of the product/service that you are involved in;
• Having good relationship with authorities is an advantage.
• Good experience and knowledge in medical equipment and consumables in Healthcare Industry.
• Multi- tasking management
• Good English or other language in both spoken and written.
• Proactive and solutions finder
• Teamwork
• Attention to detail and the ability to maintain confidentiality of product registration documents.
• Strong organizational skills and take initiative.
• Strong administration and organizational skills
• At least College&039;s degree or above (in Medicine/ Pharmacy/ Legal or equivalent) or bachelor&039;s degree with related experiences.
• Minimum 1- 3 years of experience or in the same position (prefer in medical device industry).
• Analytical skills
• Proficiency in MS Word, MS Excel and MS Outlook.

Thưởng
Chăm sóc sức khoẻ
13th salary, performance bonus
Personal health insurance

Cập nhật gần nhất lúc: 2024-12-06 08:10:02