- 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
경력 및 자격요건
- 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**
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
