Meet Your Quality & Regulatory Partner
Leonel Vanegas brings 28+ years of hands-on regulatory, quality, and R&D experience across medical devices, combination products, diagnostics, and pharmaceuticals. His career spans leadership roles at Johnson & Johnson, Abbott Vascular, Medtronic, Amgen, Merck, Alexion, and Gilead — from bench engineering to director-level quality and regulatory strategy.
Leonel brings vast experience across combination products, medical devices, IVDs and pharma. He began as a transdermal drug-delivery formulation scientist and progressed through highly demanding roles in Quality and Regulatory for Class I-III Medical Devices and Combination Products.
Today, through Precision Regulatory Consulting, Leonel partners with MedTech startups and Fortune 100 manufacturers to navigate FDA, EU MDR/IVDR, QMSR, and global regulatory pathways. His approach: operator-grade strategy, not consultant slide-ware. He now leads FDA, EU MDR/IVDR, QMSR and 21 CFR Part 4 programs for clients from Mid-Size Biotech/MedTech firms to Series-A biotech startups.
Credentials & Expertise
- FDA 510(k), De Novo, PMA, IDE submissions
- EU MDR/IVDR Technical Documentation & Notified Body audit defense
- 21 CFR Part 4 Combination Products (RFD strategy)
- QMSR 2026 transition & ISO 13485 implementation
- AI/ML SaMD regulatory strategy (PCCP, GMLP, EU AI Act)
- MDSAP multi-site audit preparation
- IND/NDA/BLA eCTD authoring (Modules 1-5)
- LATAM regulatory (ANVISA, COFEPRIS)
- RAPS – RAC Device Certified
- ASQ CQE, CQA, CSSBB, CMQ-QA
- Certified in EU MDR 2017/745
Career milestones
- 1997 — Started in transdermal drug delivery; first TDS patent for Parkinson’s Disease.
- 2008 — Principal Design Assurance & Reliability Engineer for Class III cardiovascular devices.
- 2020 — Led regulatory and quality strategy for various injectable combination products.
- 2024 — Founded Precision Regulatory Consulting LLC.
What I bring to your program
- Operator-grade regulatory strategy — not consultant slide-ware.
- Hands-on document authoring: 510(k) eSTAR, EU MDR Technical Documentation, QMSR procedures.
- Direct relationships with FDA Pre-Submission reviewers, three EU Notified Bodies, and LATAM authorities (ANVISA, COFEPRIS, INVIMA).
- Bilingual EN/ES — extends seamlessly into LATAM and Spain.