南京招聘

Business Segment

Healthcare Quality

About Us

GE (NYSE: GE) works on things that matter. The best people and the best technologies taking on the toughest challenges. Finding solutions in energy, health and home, transportation and finance. Building, powering, moving and curing the world. Not just imagining. Doing. GE works. For more information, visit the company's website at www.ge.com

Role Summary/Purpose

This position provides subject matter expertise and directly leads a team to ensure that GEHC establishes and implements best practices within the assigned area of responsibility (regional regulatory submissions & reporting, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, etc).

Essential Responsibilities

1. Creates and files submissions; communicates with authorities regarding these submissions.

2. Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions

3. Leads a team to execute on global submissions for assigned product line or new product introductions.

4. Ensures teams compliance with pre- and post-market product approval requirements

5. Works closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop and implements company-wide programs and processes for regulatory affairs compliance within areas of responsibility.

6. Communicates and trains business on new or changing requirements and provides solutions for their implementation, ensuring business goals are met.

7. Analyzes and drives team to improve overall performance metrics to be best in class

8. Supports continuous improvement activities with regard to areas of responsibility.

9. Drives the development and execution of regulatory strategy and update strategy based upon regulatory changes

10. Provides RA oversight to clinical studies and ensure clinical data requirements for product licensing globally are documented in the compliance plan.

11. Supports regulatory inspections as required.

12. Participates in professional associations, industry/ trade groups and appropriate standards organizations.

13. If managing a team, provides leadership and facilitates problem resolution, resource utilization, career counseling, mentoring and development of team members.

Qualifications/Requirements

1. Bachelor's Degree or a minimum of 10 years work experience.

2. Minimum of 5 years experience working in a regulated medical device or pharmaceutical industry.

3. Minimum of 1 year supervisory/management or project leadership experience

4. Ability to communicate effectively in English (both written and oral).

5. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

Quality Specific Goals:

1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.

2. Complete all planned Quality & Compliance training within the defined deadlines.

3. Identify and report any quality or compliance concerns and take immediate corrective action as required

Desired Characteristics

1. Advanced degree in scientific, technology or legal disciplines

2. Minimum of 5 years supervisory/management experience is preferred.

3. Regulatory Affairs Certification (RAPS)

4. Experience with Pre & Post Market submissions such as PMAs, 510(k)s, MDRs

5. Knowledge of international regulatory requirements, including Canada, China, Europe, Japan, Korea, Latin America, & United States.

6. Statistics education and or training

7. Ability to work independently in fast-paced environment with little supervision.

8. Ability to adapt to constant change and influence positive change effectively.

9. Team-oriented and responsive to customer needs.

10. Attention to Detail and Results-Oriented.

11. Ability to understand technical documentation and execute associated procedures

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。