A Day in the Life 

The Sr Regulatory Affairs Specialist will be based in our Glass Tower, Seoul office. This is a unique opportunity to join the Regulatory Affairs Team to ensure the appropriate licensing, marketing, and legal compliance of a range of our medical devices to control their safety and efficacy mainly for Cardiovascular and Diabetes products. 

Roles & Responsibilities

* Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections

* Leads or compiles all materials required in submissions, license renewal and annual registrations

* Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance

* Monitors and improves tracking / control systems

* Keeps abreast of regulatory procedures and changes

* May direct interaction with regulatory agencies on defined matters

* Recommends strategies for earliest possible approvals of clinical trials applications

* Direct communication with global stakeholders

* Work in collaboration with KGMP

* Regular registration status update to global and local stakeholders

Must-Have

* Completed Bachelor`s degree in any discipline 

* 6 - 8 years of experience in a regulatory affairs role in medical devices or pharma industries

* Good understanding and working knowledge of QARA Operations

* Must have effective written and verbal communication skills in both English and Korean languages 

* Excellent stakeholder relationship management

* Achievement oriented and ability to drive results with the highest quality standards

* Computer skills (excellent knowledge of MS Office products)

Nice-to-Have

* Medical devices and class IV product licensing experience is highly regarded

* Korea Good Manufacturing Practice experience is a plus