Regulatory Affairs Specialist

Regulatory Affairs Specialist

[접수기간]

22년 9월 13일 ~ 채용 시 마감

[전형절차]

서류 > 면접

[담당업무]

- Responsible for execution of Class I/II/III medical device and IVD product registrations
- Regulatory agency communications (e.g. MFDS, KTL, KTR, KTC, etc)
- Assist in RA SOP development and adhere to internal audit requirements per QMS
- Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions

[자격요건]

- Major in Science or Engineering
- Shall have a minimum 2 years of experience in regulatory affairs of medical device / IVD or any other regulated industry
- Working knowledge of the applicable standards and how to apply them effectively
- Korea Regulatory Affairs Certification and knowledge in GxP's(GCP, GLP & GMP) would be an added advantage

[채용공고]