Regulatory Affairs Director for USA
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- 회사개요 : 국내 체외진단 전문기업
- 모집기간 : 채용시까지
◈ 직무 개요
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise
on the submission strategy
- Timely compile materials for license renewals, updates and registrations
- Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Timely compile materials for license renewals, updates and registrations
- Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Review labeling and labels for compliance with regulatory requirements
- Provide the regulatory reviews of customer complaints and define the regulatory report ability
- Responsible for timely registration of the facility
- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
- Actively participate in evaluation of regulatory compliance of document / product changes
◆ Core Job Responsibilities:
- Complete submissions to US FDA regulatory entities.
- Create and maintain product US FDA technical files.
- Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
- Supervise Regulatory Affairs consultants as required.
- Other duties as assigned
- Provide the regulatory reviews of customer complaints and define the regulatory report ability
- Responsible for timely registration of the facility
- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
- Actively participate in evaluation of regulatory compliance of document / product changes
◆ Core Job Responsibilities:
- Complete submissions to US FDA regulatory entities.
- Create and maintain product US FDA technical files.
- Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
- Supervise Regulatory Affairs consultants as required.
- Other duties as assigned
◈ 경력 요건
- Requires BA degree in a science or related field
- At least 15 years relevant experience within the regulatory affairs discipline for Regulatory Affairs Director and at least 5 years for Junior(or Senior)
- Regulatory Affairs Specialist.
- Knowledge of US IVD regulatory requirements
- Experience with IVD is mandatory
- Former experience at FDA or IVD manufacturer(Cepheid, Abbott, Roche and so on) is a plus
- Knowledge of US IVD regulatory requirements
- Experience with IVD is mandatory
- Former experience at FDA or IVD manufacturer(Cepheid, Abbott, Roche and so on) is a plus
◈ 처우
- Negotiable
◈ 제출 기한
- ASAP
◈ 제출 서류 및 기타
- 영문 이력서 및 자기소개서
◈ 담당 컨설턴트
- 노경주 전무 / 02-2016-6605 / joshua@vpeople.co.kr
`22.01.05(updated. `22.02.15)