KEY RESPONSIBILITIES（主要职责）

1. Identify and implement effective process control systems to support the development, validation, and ongoing manufacturing of products.

2. Act as an effective leader or team member in supporting quality disciplines, decisions and practices.

3. Review and developing the QA policies and procedures compliance with the cooperate, FDA and other regulatory requirements.

4. Audit compliance with QA policies and procedures. Report audit results to upper management. Work with other managers to create plans for moving toward compliance.

5. Recommend changes to polices, procedures where appropriate based on industry “best practice” and regulatory requirements.

6. Provide and document staff training on quality-related policies, tools for improving meetings, tools for problem solving with numbers and tools for problem solving with ideas.

7. Assist in the development and management of the QA/RA/SMS budgets.

8. Supervisory responsibilities include staff development and hiring, firing, and evaluation of staff.

9. Responsible for developing contracts, and monitoring contractors, for outside QA/QC audits.

10. Supervise preparation of marketing authorization applications for new medical devices products.

11. Ensure that document is correct and complete and submitted in due time to the national regulatory agency consistent with the company’s strategic goals for marketing, manufacturing, and selling. Follow up with regular FDA surveillance reports to maintain or renew existing marketing authorizations. Inform national regulatory authorities without delay of reported adverse reactions/side-effects.

12. As the primary company contact with the national regulatory agencies, strength in agency negotiations, formation of strategy for responses to data deficiencies, information and policy monitoring, and acceleration of the review process are required.

13. Developments of the medical devices products supervise preparation, and negotiate with regulatory agencies for approval. Provide input to the International Regulatory Affairs staff on development of regulatory requirements and policies within China.

14. Keep company management up to date on status of specific product registration actions, problems and solutions. Further, inform management of changing or new national/international legislation and policies of the medical devices, as well as pertinent scientific and political inputs and influences. In this context form strong professional relationships with key-influential political, regulatory and trade association contacts. Attend external seminars, briefings and conferences.

15. Developments of the ETO sterilization process, validation and operation management compliance with cooperate, FDA and local regulatory requirement.

16. Responsible for the sterilized product release according to the cooperate policies and procedures.

17. Performs other duties as may be required by supervisor.

SKILLS AND ABILITIES（技能）

1. Bachelor’s degree from a 4-year accredited institution.

2. Relevant manufacturing management experience in the medical device field and more than 6 years experience.

3. In-depth knowledge of FDA requirements including management controls, Design Controls, Corrective & Preventative Action, Production and Process Controls.

4. In-depth knowledge of applicable regulatory affairs laws, regulations and policies, both national and international.

5. Broad knowledge of industry standard “best practices” for Quality Assurance. Demonstrated ability to plan, schedule and coordinate including initiation, development, implementation, and maintenance of large, difficult and complex development projects.

6. Commitment to providing excellent customer service.

7. Good organizational abilities, oral communications in both Chinese and English and interpersonal skills are needed.

8. Expert ability to write and present effective project materials, including presentations, status-reporting, etc.

9. Expert ability to lead effective project meetings that are tailored to the participants.

10. Expert ability to effectively identify and resolve project issues.

11. Ability to work in a high stress, high productivity and rapidly changing environment.

12. Ability to be a “self-starter” who identifies, resolves, and reports on issues in a timely and effective manner.

Founded in 1897, BD is a world-wide leader of medical technology which manufactures and sells a broad range of supplies, devices and systems for use by healthcare professionals, medical research institutions, industry and the general public. We focus strategically on achieving growth in three worldwide business segments-BD Medical System (Core Medical, Consumer Healthcare, Pharmaceutical Systems, Ophthalmic Systems), BD Biosciences and BD Preanalytical Solutions. Our products are marketed in the United States and around the world. The latest Fortune magazine has listed BD in the top four “America’s Most Admired Companies” in the medical products, equipment category.
We believed in “Do what is right, Always seek to improve, Accept personal responsibility, Act in harmony.” Now we invite qualified, talented and self-motivated individual to develop with BD’s businesses in China.