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.

[근무조건]

근무 형태: 정규직

근무 요일/시간: 주 5일(월~금)

근무 지역: 서울 영등포구 여의도동

급여: 회사내규에 따름

[문의사항]

전화: 02 - 829 - 6511
E-mail: yeonsoo.kim@bayer.com

[기타 안내사항]

- 면접은 서류전형 합격자에 한해 개별통지 합니다

- 국가보훈대상자와 신체장애자는 관련서류 제출시 관계법에 따라 우대합니다

- 남자는 병역필 또는 면제자로 해외출장에 결격사유가 없는 자를 모집합니다

- 제출하신 서류는 일체 반환하지 않습니다.

- 입사지원서 내용에 허위사실이 판명될 경우 입사가 취소될 수 있습니다.

- 신체적 조건과 출신 지역, 혼인 여부, 재산, 구직자 직계존비속 및 형제자매의 학력, 직업, 재산과 관련된 정보는 지원서류에 포함하지 마십시오. 

(단, 바이엘코리아에 재직 중인 가족이 있을 경우, 회사가 공정한 채용을 위한 조치를 취할 수 있도록 입사지원서를 통해 사전에 고지해 주시기 바랍니다.)