What services does lilac0309 offer?

lilac0309 offers Regulatory Pathway Assessment, De Novo & PMA Strategy, QMS Setup & Implementation and other FDA regulatory consulting services for medical device companies.

What regulatory pathways does lilac0309 specialize in?

lilac0309 specializes in 510k, De Novo and other FDA regulatory pathways for medical devices.

What is lilac0309's regulatory experience?

lilac0309 has 13+ years of experience in FDA regulatory affairs.

lilac0309

Senior Regulatory Affairs Leader

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 collabora...

Experience: 13+ years

Expertise & Specializations

Regulatory Pathways

510kDe Novo

Regions Served

lilac0309 provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Asia-Pacific

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510kDe Novo

Services Offered

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.

De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.

QMS Setup & Implementation
Quality management system design, implementation, and validation to meet FDA and ISO requirements.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US, EU, APAC
Background: 13+ years of regulatory experience.

Cruxi view

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.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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