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注冊法規事務副經理（醫療器械行業）-Shanghai

碧迪醫療器械（上海）有限公司

上海

03-14 發布

職位信息

職位名稱：注冊法規事務副經理（醫療器械行業）-Shanghai

類別名稱：

職位描述：

職位描述：Position SummaryWorking in a team of regulatory affairs professionals to ensure best practices within the assigned area of responsibility, e.g. CFDA/CE pre-market submission, approval, regulatory reporting, design controls for new product development, technical standards, collection and dissemination of intelligence, influencing the local and global regulatory environment, etc..Key Responsibilities1.Establish/execute a thorough submission plan for each assignment within the timeline agreed by stakeholders;2.Work with diversified team to develop and execute regulatory strategy for complex local manufacture products and maintain existing licenses;3.Interact with CFDA/Provincial FDA on registration/manufacturing regulation requirements and monitor changes to requirements.4.Interact with manager as required by specific issues, milestones, or status changes.5.Manage the regulatory review of labeling, promotional materials, technical documents, clinical protocols, and clinical reports for products that are under his/her responsibilities.6.Ensure compliance with China regulatory requirements from pre-market perspective, including but not limited to change management, Chinese labeling requirements, etc..7.Monitors regulatory and standards developments affecting BD product he/she is responsible for, identifies and recommends committees that BD should be part of.Skills and abilities1.Ability to communicate (oral/written) and interact effectively across all levels, disciplines, functions, and regions, particularly with regulators. Independently write reports/documents for distribution within division.2.Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas.3.Ability to confidently deal with ambiguous issues and provide input towards suitable actions.4.Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers/approvals with CFDA/CE authority.5.Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues.6.Minimum 6 years working experience in medical device regulatory affairs, experience in infusion products will be a plus.7.Interpret subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations.8.Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes.9.Independently manage and monitor multiple complex and diverse short term and long-term projects without direct supervision. Interact with manager as required by specific issues, milestones, or status changes. Maintains a “focused urgency” as required.10.Good communication skills, able to work under pressure, delivery orientated, willing to travel.DesirableB.S. or B.A. degree in a technical discipline.

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