About

Victoria
Nadershahi

Regulatory Affairs & Quality Assurance Consultant

With over 20 years of combined government and industry experience, Victoria brings a rare perspective to medical device regulatory consulting — having served inside the FDA before guiding companies through its processes. She founded Drua Consulting to make expert regulatory guidance accessible, precise, and efficient.

Former FDA Investigator FDA 510(k) EU MDR / CE Mark ISO 13485 ISO 14971 Health Canada Bilingual EN/RU
Victoria Nadershahi
20+
Years of Experience
3
Advanced Degrees
FDA
Former Investigator
Intl.
Global Regulatory Reach

Areas of Expertise

🏛️

FDA Regulatory Affairs

510(k) submissions, PMA applications, De Novo requests, and IDE applications. Deep insider knowledge of FDA processes and expectations.

🌍

EU MDR & CE Marking

Technical files, clinical evaluations, and conformity assessments for Class I, IIa, IIb, and III medical devices under EU MDR 2017/745.

✅

Quality Management Systems

ISO 13485 implementation, audit preparation, CAPA management, and QMS gap assessments for medical device manufacturers.

⚠️

Risk Management

ISO 14971 risk management file development, hazard analysis, and risk-benefit evaluation throughout the product lifecycle.

🔬

FDA-Regulated Industries

Comprehensive guidance across medical devices, foods, dietary supplements, cosmeceuticals, and combination products.

🤝

Government Liaison

Facilitating communication between industry and regulatory agencies. Experienced in interfacing directly with FDA and international regulatory bodies.

Career Timeline

Aug 2021 — Present
Regulatory Affairs & Quality Assurance Consultant
Drua Consulting · Freelance · International
Providing comprehensive consulting services for FDA-regulated products to medical device startups and established manufacturers worldwide.
May 2017 — Aug 2021
Vice President, Quality Assurance & Regulatory Affairs
Perimetrics, LLC · Greater Los Angeles Area
Led all RA/QA functions for a medical device company, overseeing regulatory strategy and quality system management.
Jun 2012 — Jun 2016
VP of Regulatory Affairs & Quality Assurance
Proa Medical · Los Angeles, CA
Directed RA/QA for an innovative medical device company focused on high-throughput development and commercialization. Guided products from concept through FDA and CE Mark approval to commercial practice.
Oct 2007 — May 2011
Consumer Safety Officer (FDA Investigator)
U.S. Food and Drug Administration · Los Angeles Imports Division
Protected public health by assuring the safety, efficacy, and security of medical devices, drugs, biological products, foods, cosmetics, and radiation-emitting products. Gained unique insider knowledge of FDA inspection and enforcement processes.
Sep 2005 — Aug 2006
Regulatory Affairs Coordinator
Discus Dental, Inc.
Managed 510(k) and Technical File submissions for Class I and II medical devices. Ensured compliance with QSRs and ISO 13485. Liaised directly with FDA and international regulatory agencies.

Education

Master of Business Administration
Business Administration
University of Southern California
Master of Bioscience
Regulatory Science
Johns Hopkins University
Bachelor of Science
Biological Sciences
University of California, Irvine

Ready to Navigate Regulations with Confidence?

Whether you need a 510(k) submission, EU MDR compliance, or ISO 13485 guidance — Victoria brings the expertise and insider perspective to get it right.

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