Regulatory Affairs Manager - South Korea

Korea, Republic of

**Regulatory Affairs Manager**

The Regulatory Affairs (RA) Manager plays a critical role in contributing to Hologic’s success by overseeing the development, implementation, and maintenance of regulatory strategies aligned with corporate objectives. This role leads a small regulatory team and collaborates cross‑functionally to achieve regulatory goals while ensuring the highest standards of compliance, product safety, and efficacy.

**What To Expect:**

**Regulatory Strategy & Compliance**

+ Develop and execute regulatory strategies for product registrations, submissions, and approvals in compliance with local regulations and guidelines, including the Korean Medical Devices Act.
+ Monitor and interpret changes in the regulatory environment and provide strategic guidance to internal stakeholders on potential impacts.
+ Build and maintain strong relationships with regulato...