Chi tiết công việc QA/RA Specialist (HN, Hybrid) tại CÔNG TY TNHH PERSOLKELLY VIỆT NAM
Job Title: QA/RA Specialist EM, Vietnam
Job Function: Regulatory Affairs
Reports to: QA/RA Manager, Southeast Asia & South Asia (based in Malaysia)
Work Location: Hoan Kiem District, and Hybrid
Job Summary
Responsible for managing all facets of regulatory support to all Zimmer Biomet segments products. This includes developing regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for regulations and interacting with government authorities in Vietnam and Myanmar. An understanding of Zimmer Biomet products and their use as well as an understanding of the regulations and their application is required. The role will carry out activities of the Vietnam Representative office assigned by management which may include preparation of document for audit purpose or answer related questions from the local authorities.
Principal Duties and Responsibilities
- 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 requirements 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.
