Job description


  • Entry level
  • No Education
  • Salary to negotiate


North AP Regulatory Affairs Leader - Medical Products Division - Beijng, China-182225
The Medical Products Division is looking for an experienced Regulatory Affairs Professional to lead our North Asia Regulatory team.
In this role, you will provide direction, support, and leadership to the North Asia Regulatory Team. You will execute on business goals and priorities in a manner consistent with Regulatory Affairs’ global functional plan and the Gore culture.
The ideal candidate will:
Be passionate about regulatory affairs leadership in support of the registration of state-of-the art implantable medical devices
Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
Recognize the importance of building and maintaining strong interpersonal relationships
Responsibilities include:
Develop a highly functioning results-oriented North Asia regulatory team
Coordinate and ensure completion of North Asia regulatory submissions, approvals and other activities
Collaborate with stakeholders to ensure appropriate project prioritization and project deliverables                                                                                                   
Work with product regulatory associates and other internal stakeholders to develop and implement North Asia regulatory strategies and plans
Foster and maintain strong relationships with internal stakeholders to enable information sharing and effective, collaborative decision making
Effectively communicate project status to internal stakeholders
Work closely with QA, PSG and sales teams to ensure regulatory compliance in post market practice
Foster and maintain key relationships with North Asia regulatory agencies, local testing centers, industrial associations and other relevant external organizations
Plan short and long-term regulatory resource needs within North Asia
Support the development and success of regulatory associates
Collaborate with cross-functional teams to implement relevant North Asia requirements into the quality system. Assist with internal and external quality system audits
Evaluate risk and safety issues and recommend regulatory solutions
Required Qualifications:
Bachelor's degree
6 years of directly applicable regulatory affairs work experience + 3 years team leading experience in China for a medical device, pharmaceutical, life science or bio-tech company
Demonstrated prioritization, organizational, and planning skills, including action oriented, focused urgency and driving for results to meet business goals and objectives
Demonstrated problem solving skills including situations that include ambiguity
Demonstrated ability to develop, influence, empower, and lead others
Demonstrated project management experience
Proficient English written and oral communication skills, manifested as the ability to express regulatory information accurately, clearly, and succinctly
Success working across multiple geographies including, but not limited to China and the US
Ability to travel as necessary domestically and internationally to achieve business and project objectives
Desired Job Qualifications:
Team leadership experience
Experience with combination products (drug-device)
Experience with clinical trials
An advanced degree
Job:  Clinical/Regulatory
Primary Location:  Asia Pacific-China-Beijing-Beijing
Travel:  Yes, 10 % of the Time
Shift:  Day (1st shift)

About the company

Gore is a materials science company whose associates are driven by curiosity and the opportunity to improve lives through our products and innovations.

Working closely and collaboratively with our customers, we devise best-fit solutions that work the first time and every time — delivering a high standard of reliability expected by our customers and the people they serve. With products ranging from medical devices that treat aneurysms to high-performance GORE-TEX® Fabrics, and with over 2,000 patents granted in our 55-plus-year history, we’re committed to innovations that improve lives.

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