What services does Liliana Marghitoiu offer?

Liliana Marghitoiu offers Regulatory Pathway Assessment, Classification Assessment, Predicate Analysis, Test Strategy, 510(k) Authoring & Submission, De Novo & PMA Strategy and other regulatory consulting support depending on project needs.

What pathways does Liliana Marghitoiu support?

Liliana Marghitoiu supports 510(k), PMA, IDE, Q-Sub and related FDA lifecycle activities.

What specialties does Liliana Marghitoiu work in?

Liliana Marghitoiu commonly supports IVD, Other device areas.

How much regulatory experience does Liliana Marghitoiu have?

Liliana Marghitoiu has 17+ years in regulatory and quality work.

Liliana Marghitoiu — 510(k) & PMA Consultant (IVD/Other)

Q: What regions does Liliana Marghitoiu serve?

Regions served include: United States (FDA), European Union (MDR/IVDR), Canada (Health Canada), Asia-Pacific, Latin America.

Regulatory Affairs Director

Accomplished Regulatory Affairs Director with extensive expertise in guiding the complete product lifecycle for medical devices, diagnostics, biologics, gene therapies, and combination products. Proven track record of leading cross-functional teams and securing global approvals from concept through commercialization. Highly proficient in navigating complex regulatory environments and managing glob...

Experience: 17+ years

Expertise & Specializations

Regulatory Pathways

510(k)PMAIDEQ-Sub

Device Specialties

IVDOther

Regions Served

Liliana Marghitoiu provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)Canada (Health Canada)Asia-PacificLatin America

Credentials & Recognition

Education & Credentials

Possesses advanced degrees in Regulatory Affairs and Clinical Affairs from the University of Southern California, complemented by a Master's in Biotechnology and Bioinformatics from CSU Channel Islands. This strong academic foundation, including a Bachelor's in Chemistry and Physics, equips them with a comprehensive understanding of scientific principles and regulatory pathways crucial for navigating the complexities of the medtech industry.

Authored several impactful publications in reputable scientific journals, including the PDA Journal of Pharmaceutical Science and Technology, focusing on critical areas such as extractables and leachables analysis. This recognized thought leadership demonstrates a deep engagement with and contribution to scientific and regulatory advancements within the industry.

Professional Experience

A seasoned Regulatory Affairs Director with extensive experience leading global regulatory strategies for diverse product types including medical devices, diagnostics, biologics, and gene therapies. Proven success in guiding products from R&D through global commercialization, managing complex submissions, and serving as a key liaison with regulatory authorities. Demonstrated expertise in leading quality assurance, clinical trial compliance, and implementing critical frameworks such as SDLC, Design Controls, and Risk Management across various reputable organizations.

Executive Summary

Professional Overview

Core Specializations

Regulatory Pathways

510(k)PMAIDEQ-Sub

Device Specialties

IVDOther

Services Offered

ISO 13485 Consulting
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.

FDA Mock Audit
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.

ISO 14971 Consulting
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.

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

510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.

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.

Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

• MedTech companies seeking expert regulatory guidance

Experience signals

Regions: US, EU, CA, APAC, LATAM
Background: 17+ years of regulatory experience.

Cruxi view

With 17 years of experience as a Regulatory Affairs Director, Liliana Marghitoiu specializes in guiding medical devices, diagnostics, biologics, and gene therapies through the complete product lifecycle, securing global approvals from concept to commercialization. Her expertise in navigating complex regulatory environments and managing global submissions, including IND, BLA, 510(k), PMA, CTA, IDE, CE Mark, and EUA, with FDA, EMA, and other international agencies, sets her apart. Liliana's proficiency in leading quality assurance, clinical trial compliance, and implementing critical frameworks such as SDLC, Design Controls, and Risk Management further solidifies her strengths. Her proven track record of successfully managing cross-functional teams and securing global approvals demonstrates her ability to drive product lifecycle management. With a deep understanding of scientific principles and regulatory pathways, Liliana is an expert regulatory affairs leader, making her an invaluable asset for medtech companies.

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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