Liliana Marghitoiu
Expert Regulatory Affairs Leader | Global Approvals | Devices, Biologics, Gene Therapies | FDA & EMA Navigation
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 global submissions (IND, BLA, 510(k), PMA, CTA, IDE, CE Mark, EUA) with FDA, EMA, and other international agencies. Adept at leading quality assurance, clinical trial compliance, and regulatory operations, with a deep understanding of SDLC, Design Controls, and Risk Management frameworks.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), PMA, Pre-Sub / Q-Sub
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
17
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd, other
Technology Types:
ivd_test, combo_product
Accepting New Clients:
No
