Tuyển dụng senior regulatory & quality specialist - medical devices (id: 527641) tại Hà Nội

Mô tả công việc
OVERVIEW:
Senior / Specialist, Regulatory Affairs and Quality, Vietnam is responsible for supporting functions related to gaining market access for the regulated products including submissions, communications with regional and business teams, collection of materials, analysing and preparing responses on all governing agency actions.
JOB DESCRIPTION:
Support in issuing and changing processes and procedures to fit in local statutory and regulatory requirement
Prepare, submit, and manage regulatory applications required for product market approvals in Vietnam
Collate and prepare all materials, reports and follow-ups with regulatory agencies regarding recall activities
Perform other ad hoc initiatives / activities as per request from function
Support post-market surveillance activities i.e. complaint Investigations, FSCA, MDR, etc.
Participate in internal and external quality system and design dossier audits
Commits to quality - adheres to and improves processes and works
Implement, maintain and support local submission processes and global processes
Coordinate with local consultants and agents who support regulatory submissions
Support re-labelling, second labelling, translation processes when needed