Sr. Regulatory Affairs Specialist

채용제목 Sr. Regulatory Affairs Specialist 회사소개 미국계 글로벌 의료기기 회사 업무내용/자격요건 [담당직무]
[Position Summary]

Sr. Regulatory Affairs Specialist is responsible for leading regulatory submission strategies, ensuring compliance with applicable regulations, and serving as a key liaison between local authorities, global RA teams, and internal stakeholders. This role requires in-depth regulatory knowledge, project leadership skills, and the ability to guide junior team members.

 

[Key Responsibilities]

 

1. Regulatory Strategy & Submission Management

Develop and prioritize strategies for regulatory approvals, including new product registrations, license renewal, license re-evaluation, and KGMP certifications (excl. KGMP recertification), for assigned product lines
Ensure timely submissions and approvals through high-quality regulatory applications aligned with planned or committed timelines
Collaborate with global and regional RA peers to a...

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