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Regulatory Affairs Manager - South Korea

Company

Hologic, Inc.

Location

South Korea, South Korea

Type

Full-time

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 regulatory authorities, industry associations, and relevant bodies to ...
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