Regulatory Affairs Manager, Digital Solutions APAC


[Job Description]

1. Responsible to provide regulatory support to APAC Radiology teams (Supply Chain, Order to Cash, Marketing, Legal, Quality, Services, Commercial…) depending on the need for digital products.

2. Responsible for the development, alignment and implementation of regulatory strategies in support of new product digital initiatives and product line extensions in APAC region.

3. Leads APAC input for Global digital Regulatory Affairs project initiatives.

4. Acts as a company liaison to industry trade associations for digital topics.

5. Leads the preparation and maintenance of dossiers for APAC registration of digital products, in coordination with global regulatory affairs (GRA) teams; draft and compile the dossier for submission when needed.

6. Interact with Notified Body or Health Authorities when needed to support registration of digital products.

7. Responsible to monitor and communicate APAC regulatory policies/requirements (draft or final) for digital products with the global regulatory team.

8. Liaise with 3rd party partners to assess digital opportunities.

9. Provide digital product assessments to regional and global teams (local regulations, project development, product change assessment etc.).


[Qualifications / Requirement]

- Ph.D., M.D., P.Eng. or PharmD with minimum of 5 years of regulatory device experience, or a Master's with a minimum of 7 years of Regulatory device experience; or a Bachelor's degree with a minimum of 9 years of Regulatory device experience.

- Good understanding and experience in APAC country registrations, especially for the main countries such as South Korea, Singapore, Australia, etc., registration experience related to AI and software as medical device would be preferable.

- Good knowledge of international QMS regulations (ISO 13485, GMP, MDSAP), and assessment/management of design changes, labeling, QA/QC, etc.

- Advanced level in Korean and English on both written and oral communication skills.

- Pro-active personality with excellent organizational, communication, interpersonal and problem-solving skills, strategic thinking, project management, team spirit.



근무 형태: 정규직

근무 요일/시간 5(~)

근무 지역서울 영등포구 여의도동

급여회사내규에 따름



전화: 02 - 829 - 6511

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