핵심 정보
- 경력
- 경력 12년 ↑
- 학력
- 대졸(4년제) 이상
- 근무형태
- 정규직
- 우대사항
-
- 활동/경험해당직무 근무경험
- 급여
- 회사내규에 따름
- 근무요일
- 주 5일(월~금)
- 근무지역
- 서울 강남구
본 채용정보는 마감되었습니다.
HeNny & McCoy에서 채용공고가 시작되면 이메일로 알려드립니다.
상세요강
▣ Korean Title: 부장급
▣ Responsibility
This position has responsibility and authority for:
- Support RA&QA director to ensure compliance of ISK QMS per medical device regulations and company standards.
- Support quality responsible in development, maintaining and enhancing the internal processes to compliance to the local medical device regulations and Intuitive processes
- Develop long range regulatory, quality or compliance projects together with the corporate headquarters to ensure implementation of applicable regulation and guidelines
- Work closely with ISK RAQA staffs on overall regulatory and quality affairs
- Work closely with business dept and related parties within ISI, and regulatory agencies to manage regulatory and quality affairs
- Develop regulatory strategies and implementation plans for the preparation and submission of new products or variations.
- Review regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Obtaining regulatory approvals for new products and variation on time to support product launch
- Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new medical devices and regulatory support of marketed products.
- Provide RAQA input for cross-functional projects including but not limited to clinical trial, market access etc.
- Closely monitor the local regulatory environmental changes to determine potential impacts on organizational processes
- Work closely with Regulatory Compliance to build advocacy for Intuitive
- Actively participate in various RA/QA projects internally and externally and lead the group in any chance
▣ Requirements
- BA in science, engineering, medical or related
- Over 12 years relevant RA&QA experiences in medical device industry
- Well-organized & focused. Strategic planning skills
- Professional communication skills and ability to work in cross-functional environments
- Proven ability to review and translate technical documentation into effective regulatory submissions
- Passionate and a great sense of responsibility
- Strong interpersonal skills with ability to lead projects autonomously and to collaborate effectively with various scientific and business representatives in international team environment
- Excellent written and verbal communication skills in both the Korean and English command
▣ Location : 서울
▣ 제출서류
- 영문(or 국문)이력서를 MS Word 파일로 담당 컨설턴트 Email로 보내주시기 바랍니다.
- 이력서에 지원분야의 경력 사항을 최대한 구체적이고 상세히 기술해 주시길 바랍니다.
- 사진 첨부요망 / 응시분야 / 연락처 / 연봉(현 연봉 & 희망 연봉) 기재
▣ Contact point : 육형아 상무
If you have any question, please do not hesitate to contact me.
Office : 02-508-7462 // Cell : 010-2459-1141
Home : www.hennymccoy.com // Email : J.Youk@hennymccoy.com
** 이메일로 접수바랍니다 (온라인으로 지원할 경우 확인이 늦어질 수 있음)**
▣ Responsibility
This position has responsibility and authority for:
- Support RA&QA director to ensure compliance of ISK QMS per medical device regulations and company standards.
- Support quality responsible in development, maintaining and enhancing the internal processes to compliance to the local medical device regulations and Intuitive processes
- Develop long range regulatory, quality or compliance projects together with the corporate headquarters to ensure implementation of applicable regulation and guidelines
- Work closely with ISK RAQA staffs on overall regulatory and quality affairs
- Work closely with business dept and related parties within ISI, and regulatory agencies to manage regulatory and quality affairs
- Develop regulatory strategies and implementation plans for the preparation and submission of new products or variations.
- Review regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Obtaining regulatory approvals for new products and variation on time to support product launch
- Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new medical devices and regulatory support of marketed products.
- Provide RAQA input for cross-functional projects including but not limited to clinical trial, market access etc.
- Closely monitor the local regulatory environmental changes to determine potential impacts on organizational processes
- Work closely with Regulatory Compliance to build advocacy for Intuitive
- Actively participate in various RA/QA projects internally and externally and lead the group in any chance
▣ Requirements
- BA in science, engineering, medical or related
- Over 12 years relevant RA&QA experiences in medical device industry
- Well-organized & focused. Strategic planning skills
- Professional communication skills and ability to work in cross-functional environments
- Proven ability to review and translate technical documentation into effective regulatory submissions
- Passionate and a great sense of responsibility
- Strong interpersonal skills with ability to lead projects autonomously and to collaborate effectively with various scientific and business representatives in international team environment
- Excellent written and verbal communication skills in both the Korean and English command
▣ Location : 서울
▣ 제출서류
- 영문(or 국문)이력서를 MS Word 파일로 담당 컨설턴트 Email로 보내주시기 바랍니다.
- 이력서에 지원분야의 경력 사항을 최대한 구체적이고 상세히 기술해 주시길 바랍니다.
- 사진 첨부요망 / 응시분야 / 연락처 / 연봉(현 연봉 & 희망 연봉) 기재
▣ Contact point : 육형아 상무
If you have any question, please do not hesitate to contact me.
Office : 02-508-7462 // Cell : 010-2459-1141
Home : www.hennymccoy.com // Email : J.Youk@hennymccoy.com
** 이메일로 접수바랍니다 (온라인으로 지원할 경우 확인이 늦어질 수 있음)**
기업정보
이 기업의 다른 공고 (72건)
- 대표자명*
- Cheolhyun(Henny) Jo
- 기업형태
- 중소기업
- 업종
- 고용 알선업
- 설립일*
- 2006년 06월 (업력 19년차)
- 기업주소
- 서울 강남구 테헤란로 151, 801호
* 항목은 기업이 직접 기재하였으며, 본사/지점 등의 정보는 다르게 관리될 수 있습니다.
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사람인 인공지능 기술 기반으로 맞춤 공고를 추천해드리는 사람인의 채용정보제공 서비스입니다.
