(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

applicable statutory requirements and any decision thereof made by top management

throughout the establishment and supply chain.

• Keeping up to date with changes in regulatory legislation and guidelines. Monitor and

timely reporting on changes or upcoming changes to medical device laws and

regulations affecting registration, distribution and sale & marketing team.

• 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

• At least College’s degree or above (in Medicine/ Pharmacy/ Legal or equivalent) or bachelor’s degree with related experiences.

• Minimum 1-3 years of experience or in the same position (prefer in medical device industry).

• Good experience and knowledge in medical equipment and consumables in Healthcare Industry.

• Good English or other language in both spoken and written.

• Proficiency in MS Word, MS Excel and MS Outlook.

• Displaying strong detailed knowledge of the product/service that you are involved in;

• Strong organizational skills and take initiative.

• Attention to detail and the ability to maintain confidentiality of product registration documents.

• Strong administration and organizational skills

• Teamwork

• Analytical skills

• Multi-tasking management

• Proactive and solutions finder

• Good communication in Vietnamese and English

• Having good relationship with authorities is an advantage.