QA/RA Specialist (HN, Hybrid)

To work closely with regional RA & Global to drive reduction of registration cycle time through Speed to Market initiatives. To define and implement Vietnam and Myanmar regulatory strategy and plan.

To manage and track Speed to Market performance for SME. To update registration metrics and update submissions/ projects on a quarterly basis. To update comprehensive commentary report on a monthly and yearly basis. To understand and help influence Vietnam and Myanmar medical device regulatory environments by leveraging key relationships with industry groups. To manage and assist distributors in all their

for import licenses, product approvals, certificates and any letters or declarations to facilitate their importation, selling and distribution. Regulatory Compliance To oversee copy review advertising and promotional materials and relevant internet activities and publications to comply with all relevant internal policies and local country regulations. To oversee and ensure development, implementation and compliance of relevant SOPs and execute regulatory operations such as Global Distribution Regulatory Controls and Regulatory Information Management System. To coordinate with Regional and Global QA on Quality field actions & post-market reporting

requirements:. To comply with all relevant local country regulations as responsible person for the establishment with the Ministry of Health and Chief Representative of the Rep Office.

Perform Bonus

Team Outing

Anual leave

Meal Allowance

THR