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※ This position opening has been closed If you have any inquiry, please contact the consultant directly for more information. |
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| :: RA Specialist (미국 지사 파견) :: | |
| Company Introduction | 국내 코스닥상장 의료기기회사 |
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| Job Description | - Prepare and manage FDA regulatory submission process, including authoring and publishing electronic submissions - Oversees the development of dossiers for registration of products in countries outside the US - Provides regulatory direction to development project teams as a core team member - Directs and oversees the work of regulatory professionals, including training, mentoring and ensuring professional development Miscellaneous responsiblities as assigned - Review and evaluates promotion and advertising material for compliance with applicable regulations - Develops regulatory strategy for new products - Review proposed product changes for impact on regulatory status of the product - Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization - Maintain Regulatory records, including archive of submissions and FDA correspondences files - Maintain and update technical files for CE marking |
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| Job Requirement | - The hired employee will be dispatched to USA office in Denver with working visa provided - Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers and direct reports - Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail - Ability to manage competing priorities; ability to manage projects of various sizes, constitutions, and management of personnel; versatility, flexibility and willingness to work with changing priorities - Advanced knowledge of overall business environment, the orthopaedic industry and the marketplace - Mastery of relevant regulations and ability to stay abreast of regulations pertinent to medical devices, biologics drugs and combination products as applicable - Ability to function well as a member of the team and team leader, as well as build relationships between RA and other area of the org. - Mastery anatomic knowledge - ** The applicants must be eligible for US work visa application** |
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| Location | 해외|해외 | Degree Level | 제한없음 |
| Career Level | [과장급] | ||
| No. of Recruitment | 0 | ||
| Salary | 협의 | ||
| Required Document | 국영문 이력서 | ||
| Others | - 원서 마감후 1차(서류) 합격자에 한하여 개별연락 - 제출된 서류는 일체 반환하지 않습니다. - 해외여행에 결격 사유가 없는 자 - 이력서에 연락처, 희망연봉 게재 |
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| Contact/Inquiry | 양혜원 / 이사 02-6281- 5015 yhw@nterway.com |
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