Regulatory Affairs Specialist (Medical Device)

Requirements:

* Candidates understand the process of AKD registration with type three Active Medical Device.

* Ability to obtain permits quickly and effectively, regardless of circumstances. (Get-it-done person)

* Strong connections with the Ministry of Health, particularly in relation to AKD permits.

* Ability to work independently as a single contributor.

* Fluent in English (proficiency in Mandarin is a plus).

* Reports directly to the Deputy General Manager.

Job Description :

* Understand the registration system for local medical devices.

* Responsible for the preparation and execution of product registration plans, and have project management capabilities to promote the on-schedule progress of registration projects.

* Track the registration process and solve various problems raised by MOH in a timely and effective manner.

* Navigate the AKD process efficiently and secure the AKD approval promptly.