lilac0309
Senior Regulatory Affairs Leader | Combination Products | Digital Health | Global Submissions
Wenjing is a senior Regulatory Affairs leader with 13 years of experience, specializing in complex biologics-device combination products, auto-injectors, pre-filled systems, and digital health technologies. She excels in developing global regulatory strategies across the U.S., EU, Japan, and China, ensuring successful submissions, design control compliance, and fostering cross-functional collaboration for intricate therapeutic and diagnostic products. With advanced degrees in Regulatory Affairs, Biochemistry, and Developmental Biology, Wenjing brings profound technical expertise and a demonstrated ability to influence in matrixed environments, support end-to-end product development, and guide teams through evolving regulatory landscapes.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, De Novo Strategy & Authoring, PMA Strategy & Support
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo
Device Types Supported:
SaMD, Medical device
Years Experience:
13
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Technology Types:
combo_product, samd
Engagement Models:
hourly
Accepting New Clients:
Yes
