의료진단기업--RA업무
페이지 정보
등록자 :
송흥용부사장
등록일 : 21-02-18 13:38
기본정보
| 의료진단기업--RA업무 | |||
| 개발 | 주임~과장 | ||
| 무관 | 무관 | ||
| 서류전형 -> 1차면접 -> 2차면접 | |||
| 2021-02-18 | 채용시 | ||
상세정보
본문(Regulatory Affairs) Job Description
- Develop effective overall product registration approval strategies for both MFDS and FDA, - Directly involves in the product approval ensuring timely market access of new products. - Provide regulatory input such as Regulatory timeline to the relevant functions in terms of new projects - Responsible for all regulatory affairs activities including GMP, product registration for MFDS - Responsible for all regulatory affairs activities for global commercialization including CLIA, cGMP, FDA 510K or PMA approval. - Close collaborating and communication with other internal functional teams - Actively participate in industry activities to influence favorable regulatory policies for company interest. Minimum Requirements - Bachelor’s degree or higher degree in related field - Minimum 3 years RA experiences in medical device, bio or pharmaceutical industry (In-Vitro Device experiences preferred) - Regulatory experience in Protein area is highly preferred - Business development experience related RA in start-up company preferred - In-depth knowledge of MFDS regulations, ISO13485 and GMP - Strong verbal and written communication in English and Korean |