Job Summary

A medical device manufacturing company needs applicants for an opening for a Remote China Market Regulatory Affairs Manager.

Core Responsibilities of this position include:

• Performing gap analysis on regulatory documentation and proposing solutions
• Representing or leading the RA function on assigned cross-functional project teams
• Preparing, reviewing, and approving labeling, SOPs, and AdProm materials for compliance with China regulations

Qualifications Include:

• Bachelor’s degree or country equivalent in a scientific discipline
• Minimum of 5 years experience in China medical device regulatory affairs
• Ability to manage complex projects and timelines in a matrix team environment
• Demonstrated experience in China medical device registrations
• Ability to lead and coach others
• Well-versed in both Chinese and English languages