天津招聘

KEY RESPONSIBILITIES

1. Prepare pre-market submissions (including type testing, registration files etc.) and obtain approval of premarket product registration timely.

2. Acts as the Regulatory partner for the BU he/she is responsible for.…

3. Interact with CFDA on registration requirements and monitor changes to requirements.

4. Independently manages and provide regulatory guidance to multiple long-term projects without direct supervision.

5. Manages a single discipline within the unit on a project or short-term basis.

6. Interacts with manager as required by specific issues, milestones, or status changes.

7. Represents company externally in long term project in specific fields.

8. Accepts accountability for RA within company on multi disciplinary platforms.

9. Manages the regulatory review of labels, labeling, promotional materials, clinical protocols, and clinical reports for products that are under his/her responsibilities.

10. Ensures compliance with China regulatory requirements, including but not limited to change management, Chinese labeling requirements, etc.

11. Monitors regulatory and Standards developments affecting company product he/she is responsible for, Identifies and recommends committees that company should be part of.

SKILLS AND ABILITIES

1. Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.

2. Ability to communicate (oral/written) and interact effectively across all levels, disciplines, and regions, particularly with regulators and Standard committee members. Independently authors written reports/documents for distribution within division.

3. 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. Assesses corrective action to assure it prevents recurrence. Able 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.

5. Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues.

6. Demonstrated success in developing strong working relationships with regulators and external groups (e.g., trade associations) in order to influence effectively and bring about consensus on policies that support business objectives.

7. Minimum 3 years of directly related experience in medical device, or pharmaceutical fields, and three or more years of management experience.

8. Interprets subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations.

9. Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. Recognized internally as technical or subject matter expert in multiple areas.

10. Suggests opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing implementation plan.

11. Independently manages and monitors multiple complex and diverse short term and long-term projects without direct supervision. Interacts with manager as required by specific issues, milestones, or status changes. Maintains a “focused urgency” as required by specific events.

12. Asserts own ideas and persuades others. Fosters collaboration among team members. Recognized as leader within department.

13. Formulates short term planning for individual deliverables/contributions and participates in long term planning within the department.

Kingfisher Recruitment Group is a global provider of Executive Search, Recruitment Process Outsourcing (RPO), Career Mobility & Transition, and Staffing Services. We are currently located in Shanghai, Beijing, Suzhou, Hong Kong, Singapore, Kuala Lumpur, Johor Bahru, Pune and Amsterdam. Established since 2003, we help clients design people strategies, attract and develop talents worldwide across industries with a focus in Healthcare & Life Sciences, Retail & Consumer, Industrial & Manufacturing and Professional Services & Technology. Our functional scope includes Data Science & Analytics, Market Research & Strategy, Digital & Technology, Accounting & Finance, Human Resources, Corporate IT, and Supply Chain.

KINGFISHER成立于2003年，是一家提供全方位招聘解决方案的跨国公司， 业务包含高端人才寻访、招聘流程外包、转职咨询和灵活用工服务。我们目前在上海、北京、苏州、香港、阿姆斯特丹、新加坡、吉隆坡、新山、印度浦那共设有9个分公司，3个人才搜寻中心，服务的客户足迹遍布亚太和欧洲。此外，KINGFISHER 在医疗、零售消费品、制造业、专业服务和信息技术行业有了超过百万的人才积累和稳定的客户群体，并在财务、人力资源、供应链、信息技术这4大职能领域累积了大量的成功招聘经验。