Primary Function :

The function of a Regulatory Affairs Manager is to be the key liaison for product regulatory matters across the MDx organization in Korea. The individual is responsible for ensuring compliance with the local regulatory requirements specific to importation and supply of MDx products in Korea.

Major Responsibilities :

• Manage the preparation and review of dossiers for new product registrations, product renewals, change notifications and other relevant regulatory applications as per local requirements in Korea.
• Effective prioritization of assignments. Strategize and implement local regulatory submission plans to achieve company objectives.
• Collaborate effectively with internal cross-functional teams and external stakeholders (eg regulators) to deliver timely regulatory submissions and approvals.
• Provides prompt and accurate regulatory assessments for planned product changes based on local product change notification requirements.
• Management of all registration related documentations in Regulatory Information Management System (RIMS) throughout the product lifecycle.
• Prompt review and approvals of product labels/artworks, advertising and promotional marketing materials to ensure compliance to current internal process and local regulations.
• Foster seamless communications with relevant internal and external stakeholders on regulatory matters related to Abbott MDx products.
• Represent Abbott MDx in internal RAC meetings and external industry meetings.
• Maintain necessary contacts with regulatory and statutory bodies, government representatives and industry associations.
• Monitor new and revised local Medical Device/IVD laws, regulations, standards, guidance documents etc. Communicate on their impact assessments and any risk mitigations to Global Regulatory and other relevant internal stakeholders.
• Provide support to internal and external audits and follow up on any regulatory affairs related action items.
• Provide regulatory support to local clinical research studies including device performance evaluation.
• Provide support on regulatory specific documentations required for Commercial Tenders.
• Supervise regulatory affairs staff and contractors, if applicable.

Education :

Masters or Bachelor’s degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

Background :

Minimum 10 years of experience in In-Vitro Diagnostics (preferred) or Medical Device regulation in South Korea.