Director Of Regulatory & Quality/ 监管与质量保证总监

JOB DESCRIPTION

Position Title: Director of Regulatory Affairs and Quality Assurance

Department: Regulatory Affairs/Quality Assurance

Reports to: CEO / VP of Production & Development

POSITION SUMMARY:

Manages regulatory affairs functions associated with medical device regulations
domestically and internationally. Develops strategies to ensure the company’s
production activities comply with government regulations. Responsible for development,
implementation and maintenance of quality assurance systems and activities.

ESSENTIAL FUNCTIONS:

1. Serves as a liaison between regulatory bodies and operating divisions of the company.

2. Prepares and submits applications and reports to applicable regulatory agencies.

Responds to requests for information from regulatory bodies.

3. Coordinates with operations departments regarding production design and
development to ensure compliance with regulations.

4. Assists with the development of standards for the company’s operating and

production procedures.

5. Maintains current knowledge of regulations applicable to the company.

6. Monitors regulatory affairs and the effect changes will have on company operations.

7. Develops and maintains professional relationships in federal, state, and local regulatory
agencies.

8. Ensures that the company’s quality system is implemented and maintained in

accordance with FDA Quality System Regulation, ISO 13485 and other applicable
standards or regulations.

9. Directs and controls activities in the following functions: receiving inspection, product

release, sterilization, complaint administration, internal auditing and supplier
management.

10. Oversees regulatory affairs pertaining to the US Food and Drug Administration,

European Community and other international medical device regulations as
appropriate.

11. Functions as primary company spokesperson with the FDA. Includes management of

all activities associated with FDA audits, filing of reportable events as well as premarket
submissions for new or changed products.

12. Conduct and/or support internal audits, client audits, and regulatory audits including,

but not limited to: audit scheduling, audit preparation, audit execution, audit
response/resolution, and audit follow-up.

13. Interacts with members of senior management to make policy decisions regarding

quality, regulatory and customer satisfaction.

14. Leads quality improvement activities and/or continuous improvement process for the
operation.

15. Enhancing product quality monitoring, identifying and prioritizing complaint trends, as

well as leading the charge on a highly effective and robust CAPA system.

16. Working Director, extremely detail-oriented

17. Implementation of strategies to achieve and enhance the individual growth of team
members.

18. Performs other related duties as assigned.

OTHER RESPONSIBILITIES:

May perform other management functions.

May require domestic and international (including China) travel.

EDUCATION, EXPERIENCE AND SKILLS REQUIRED:

BS Degree in a scientific discipline or equivalent.

Minimum of 8-12 years relevant experience with at least 5 years with documentation and
implementation of quality assurance systems, in the medical device industry.

Excellent knowledge of regulatory requirements for FDA, ISO13485, MDD/MDR & other
international r e q u i r e m e n t s

Extensive knowledge of applicable government regulations.

Ability to inform and educate managers and department heads on regulations and polices
that require compliance.

Excellent strategic planning skills.

Strong written, verbal, analytical and interpersonal skills.