lilac0309

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.

### **Additional information**

- **Type:** independent
- **Years of experience:** 13
- **Regions served:** US, EU, APAC
- **Client types:** startup, sme, large_medtech
- **Location:** United States (California)
- **Availability:** available_now

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### **Cruxi analysis**

- **Strength summary:** Wenjing, with 13 years of experience, stands out as a senior Regulatory Affairs leader specializing in complex biologics-device combination products, auto-injectors, pre-filled systems, and digital health technologies. Her expertise spans global regulatory strategies, including the U.S., EU, Japan, and China, with a focus on successful submissions and design control compliance. Her advanced degrees in Regulatory Affairs, Biochemistry, and Developmental Biology provide a strong technical foundation, complemented by a proven ability to influence cross-functional teams and navigate evolving regulatory landscapes. This combination of deep technical knowledge and global regulatory experience makes her a valuable asset for companies developing complex medical products.
- **Unique value:** Wenjing offers a unique blend of deep scientific knowledge in biochemistry and developmental biology with extensive regulatory affairs experience, particularly in biologics-device combination products and digital health, enabling her to provide comprehensive and strategic guidance through complex regulatory pathways.
- **Ideal projects:** The ideal project for Wenjing involves biologics-device combination products, SaMD, or complex Class II or Class III devices requiring global regulatory strategies, particularly in the U.S., EU, Japan, or China. She is well-suited for companies needing assistance with 510(k) submissions (traditional or special), clinical trials, QMS implementation, or De Novo pathways. Her experience makes her a great fit for companies navigating the regulatory landscape for cardiovascular, IVD, radiology, pathology, dental, or clinical chemistry devices. Companies seeking support for end-to-end product development, from initial design to market access, would also benefit greatly from her expertise.
- **Last analyzed:** Sun Dec 14 2025 01:11:56 GMT-0500 (Eastern Standard Time)

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### **Qualifications & scope**

- **Submission types:** 510k-traditional, clinical-trials, 510k-special, qms, de-novo, international
- **Device classes:** class-ii, class-i, class-iii
- **Specialties:** software-samd, clinical trials, quality system implementation, quality management systems
- **Regulatory pathways:** 510k, de_novo

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• The ideal project for Wenjing involves biologics-device combination products, SaMD, or complex Class II or Class III devices requiring global regulatory strategies, particularly in the U.S., EU, Japan, or China. She is well-suited for companies needing assistance with 510(k) submissions (traditional or special), clinical trials, QMS implementation, or De Novo pathways. Her experience makes her a g

HQ: United States

Languages: English

Status: claimed

Jurisdictions: US