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.
About
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.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 17
- **Regions served:** US, EU, CA, APAC, LATAM
- **Client types:** startup, sme, large_medtech, academic
- **Location:** United States (CA)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Liliana Marghitoiu stands out as a trusted expert in regulatory affairs, offering a unique combination of FDA experience, device expertise, and technical skills. Her ability to effectively navigate complex regulatory environments, manage global submissions, and drive product lifecycle management sets her apart. As a seasoned Regulatory Affairs Director, she brings a wealth of knowledge and expertise to medtech companies, making her a valuable asset for those seeking to succeed in the highly regulated medical device industry.
- **Ideal projects:** Liliana Marghitoiu is an ideal consultant for medtech companies seeking expertise in regulatory affairs, particularly those developing medical devices, diagnostics, biologics, and gene therapies. Her strengths lie in supporting companies navigating complex regulatory environments, securing global approvals, and managing global submissions. She excels in working with startups, SMEs, and large medtech companies, guiding them through the product lifecycle, from R&D to commercialization. Her expertise in ISO 13485 and ISO 14971, as well as her proficiency in managing global regulatory submissions, make her an excellent fit for companies seeking to expand internationally or address complex regulatory challenges.
- **Last analyzed:** Wed Dec 24 2025 00:19:34 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, qms, international
- **Specialties:** ivd, clinical-chemistry, hematology, pathology, other
- **Device panels:** ivd, other
- **Regulatory pathways:** 510k, pma, ide, q_sub
---
- **Type:** independent
- **Years of experience:** 17
- **Regions served:** US, EU, CA, APAC, LATAM
- **Client types:** startup, sme, large_medtech, academic
- **Location:** United States (CA)
- **Availability:** available_now
---
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Liliana Marghitoiu stands out as a trusted expert in regulatory affairs, offering a unique combination of FDA experience, device expertise, and technical skills. Her ability to effectively navigate complex regulatory environments, manage global submissions, and drive product lifecycle management sets her apart. As a seasoned Regulatory Affairs Director, she brings a wealth of knowledge and expertise to medtech companies, making her a valuable asset for those seeking to succeed in the highly regulated medical device industry.
- **Ideal projects:** Liliana Marghitoiu is an ideal consultant for medtech companies seeking expertise in regulatory affairs, particularly those developing medical devices, diagnostics, biologics, and gene therapies. Her strengths lie in supporting companies navigating complex regulatory environments, securing global approvals, and managing global submissions. She excels in working with startups, SMEs, and large medtech companies, guiding them through the product lifecycle, from R&D to commercialization. Her expertise in ISO 13485 and ISO 14971, as well as her proficiency in managing global regulatory submissions, make her an excellent fit for companies seeking to expand internationally or address complex regulatory challenges.
- **Last analyzed:** Wed Dec 24 2025 00:19:34 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, pma, clinical-trials, qms, international
- **Specialties:** ivd, clinical-chemistry, hematology, pathology, other
- **Device panels:** ivd, other
- **Regulatory pathways:** 510k, pma, ide, q_sub
---
Key Highlights
- 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 profic
- Liliana Marghitoiu stands out as a trusted expert in regulatory affairs, offering a unique combination of FDA experience, device expertise, and technical skills. Her ability to effectively navigate complex regulatory environments, manage global submissions, and drive product lifecycle management sets her apart. As a seasoned Regulatory Affairs Director, she brings a wealth of knowledge and expertise to medtech companies, making her a valuable asset for those seeking to succeed in the highly regu
Certifications & Trust Signals
- 17 years experience
Buyer Snapshot
Best for
- Liliana Marghitoiu is an ideal consultant for medtech companies seeking expertise in regulatory affairs, particularly those developing medical devices, diagnostics, biologics, and gene therapies. Her strengths lie in supporting companies navigating complex regulatory environments, securing global approvals, and managing global submissions. She excels in working with startups, SMEs, and large medte
HQ:
United States
Languages:
English
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
