Strategic Regulatory Affairs Consulting

25+ years of progressive experience delivering regulatory excellence across medical devices, pharmaceuticals, and combination products

25+ Years Experience
$5B+ Portfolio Value
100+ Team Members Led
Schedule Consultation View Experience
Julia Ding - Senior Regulatory Affairs Consultant

About Julia Ding

Senior regulatory affairs executive with proven expertise in leading global teams and navigating complex regulatory landscapes

Julia Ding is a seasoned regulatory affairs professional with over 25 years of progressive experience in the life sciences industry. Currently serving as a self-employed regulatory consultant since September 2024, she brings deep expertise from senior leadership roles at Fortune 500 companies including Thermo Fisher Scientific, BD, and Abbott.

Core Expertise

Combination Products

Complex regulatory pathways for drug-device combinations

Medical Devices

510(k) submissions, EUMDR compliance, global approvals

IVD Regulatory Affairs

In vitro diagnostics, CLIA waiver experience

Strategic Planning

Regulatory transformation programs and process optimization

Global Team Leadership

Managing 100+ professionals across international markets

Drug Delivery Systems

Specialized regulatory guidance for innovative delivery platforms

Consulting Services

Comprehensive regulatory affairs consulting tailored to your specific needs

📋

Regulatory Strategy Development

Comprehensive regulatory pathway planning and strategic guidance for product approvals across global markets.

📄

510(k) & FDA Submissions

Expert preparation and management of FDA submissions, including 510(k) clearances and regulatory communications.

⚕️

Combination Product Guidance

Specialized regulatory consulting for drug-device combinations and complex product classifications.

👥

Team Leadership & Optimization

Regulatory team development, process optimization, and organizational transformation programs.

🌍

EUMDR Compliance Consulting

European regulatory compliance guidance and MDR transition support for medical device companies.

🔬

IVD Regulatory Affairs

In vitro diagnostics regulatory strategy, CLIA waiver applications, and laboratory compliance guidance.

Professional Experience

Progressive leadership roles at industry-leading organizations

Sep 2024 - Present

Self-employed Regulatory Consultant

Independent Practice

Providing strategic regulatory affairs consulting services to life sciences companies across medical devices, pharmaceuticals, and combination products.

Feb 2022 - Sep 2024

Sr. Director, Regulatory Affairs

Thermo Fisher Scientific

  • Head of Life Science and Lab Products Groups RA team (>$5B revenue)
  • Managed 100+ global team members across multiple therapeutic areas
  • Led regulatory strategy for product portfolio spanning medical devices and laboratory equipment
2015 - 2022

Director / Associate Director, Regulatory Affairs

BD (Becton, Dickinson and Company)

  • Led regulatory transformation programs across product lines
  • Specialized in combination products and drug delivery systems
  • Managed global regulatory submissions and approvals
2005 - 2012

Multiple Progressive Roles

Abbott Laboratories

  • 510(k) submissions and FDA regulatory communications
  • IVD regulatory affairs expertise and CLIA waiver experience
  • Progressive advancement through regulatory affairs organization
1999 - 2003

Regulatory Specialist

ACON Biotech

  • Early career regulatory affairs foundation
  • Product registration and regulatory compliance

Get In Touch

Ready to discuss your regulatory affairs needs? Let's schedule a consultation.

Contact Information

Email: julia.ding@email.com
Phone: +1 (555) 123-4567
LinkedIn: linkedin.com/in/juliadinregulatory
Location: Available for remote and on-site consulting

Schedule a Consultation