法规注册高级经理(J12287)

职位描述

In this role, you have the opportunity to:

Shape the global regulatory strategy for high-end POCT and blood glucose monitoring devices, and lead a team to navigate complex markets like China (NMPA), Europe (MDR), and the United States (FDA).

You are responsible for:

-Developing regulatory strategies and roadmaps for Class III medical devices, with a focus on POCT and blood glucose monitoring systems

-Identifying regulatory risks in registration pathways and providing mitigation solutions

-Interpreting and applying global medical device regulations and standards; leading internal training and implementation

-Preparing, reviewing, and managing domestic and international regulatory submissions

-Acting as the primary liaison with authorities including NMPA, review centers, and testing institutes

-Tracking and analyzing regulatory updates (e.g., MDR/IVDR, FDA) and adapting strategies accordingly

-Leading and mentoring the RA team; managing regulatory schedules and deliverables across multiple product lines

任职要求

To succeed in this role, you should have the following skills and experience:

-Bachelor's degree or above in Biomedical Engineering, Pharmacy, Medical Device Engineering, or related fields

-Proven hands-on experience with Class III medical devices and clinical trial submissions

-Strong regulatory track record, including:30+ NMPA registration certificates/5+ CE certificates under MDR/3+ FDA approvals

-Familiarity with global medical device regulatory frameworks and submission processes

-Excellent communication skills, strong sense of ownership, and fluent written and spoken English

-Prior team leadership experience in a regulatory function preferred

Why Join Us:

Yuwell is a leading medical device group committed to innovation and improving lives, offering a stable yet fast-growing platform for your long-term career development.