上海招聘

Propose / develop, implement, review and update regulatory affairs strategy. Initiate activities in cope with the long-term and short-term RA strategy. Oversee the progress to ensure product registration operations to be excellent.

• Review product registration strategy and action plan. Timely make recommendations to adjust the strategy to top management team.

• Coordinates with corporate to set up registration plan based on the business needs, ensuring the business compliance with national regulations.

• Familiar with NMPA regulations, process, document review principle and technical requirements. Review registration dossier as internal examiner and guide the project team members to prepare registration documents.

• Prepare regulatory submissions and obtain regulatory permits, including import/export clearance in a timely manner

• Get Corporate RA people understand China RA policy, get aligned and work closely with them.

• Interact with and build rapport with regulatory agencies and notified bodies as required to perform effective and fast track approval of product registrations.

• Monitor the regulation development and regulatory trend in China, report the impact to the company.

• Organize and deliver regulatory education and dissemination of regulation information to the organization.

• Periodically review registration progress and issues with medical staff and other internal groups like marketing, BD, Commercial team.

REQUIREMENTS：

• Bachelor degree or above in clinical laboratory, health/life science discipline or the equivalent knowledge and experience;

• Minimum 5 years of professional experience in a regulated environment; solid relationship with authority and office.

• Solid knowledge and experience in RA of medical device (pharmaceutical preferred), ISO knowledge is preferred.

• Fluent in English and Microsoft office skills

德国美天旎生物技术有限公司成立于1989年，总部设于德国科隆，目前已经在25个国家设有分公司或代表处，拥有3000多名员工，其中包括600多名来自不同学科，如生物学、医学、物理学、机械工程等领域的优秀人才，组成了稳固的研发和技术服务团队。作为从基础科研到临床治疗完整产品线的专业的多元化公司，德国美天旎一直秉承“Researchers working for researchers”的理念，为基础科研和临床研究人员提供完整的解决方案。
自1989年公司成立以来，以专利的MACS磁分选技术享誉全球，成为磁分选领域内的金标准。公司注重不断开拓创新，产品线覆盖到生命科学研究的各个层面，包括组织处理及样本制备、细胞分选、细胞培养、流式细胞分析、分子应用和小动物成像。
2001年，德国美天旎设立中国代表处，目前美天旎中国总部位于上海，在北京、广州设有办事处。
我们的创新解决方案使得公司能够在生物医学研究、细胞治疗以及各种疾病的细胞基因治疗领域处于国际领先地位。
我们通过持续的和不断盈利的增长模式确保公司在本行业的领导地位。同时，我们忠实的客户也信任公司产品的高质量和创新的领先地位。
由于员工对公司持续奉献，我们为我们的员工感到自豪。