Meet Your Quality & Regulatory Partner
Mr. Leonel Vanegas founded Precision Regulatory Consulting LLC as its principal. In his role at Precision, he utilizes over 28 years of experience with regulated product development, quality systems for both Medical Devices and Diagnostics, Pharmaceuticals and Combination Products to provide clients with quality and regulatory consulting services.
Mr. Vanegas has been in a Quality and Regulatory capacity for Global Healthcare Organizations for almost three decades. As such, he has also participated in FDA inspections, and Audits from Competent Authorities and Notified Bodies form the EU. Mr. Vanegas holds an Masters in Science in Regulatory Affairs from San Diego State University and is certified by the Regulatory Affairs Professionals Society (RAPS) as a RAC-Devices certified. He is also certified in several quality and process improvement disciplines at the American Society for Quality (ASQ). All of the above credentials and experiences are presented exactly as they have been documented.
Leonel Vanegas experience expands across medical devices, combination products, diagnostics, and pharmaceuticals. His career spans leadership roles at Johnson & Johnson, Abbott Vascular, Medtronic, Amgen, Merck, Alexion (Astrazeneca Rare Disease) and others. Note: Employer names describe Leonel Vanegas’ individual career history and do not imply endorsement of, sponsorship by, or current client relationships with Precision Regulatory Consulting LLC.
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: pragmatic 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 21CFR part 4: Design Controls, Risk Management, Human Factors
- 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-QE
- Black Belt Lean Sigma Certified
- 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
- Experience with > 35 development and clinical trial programs for devices and combination products, including: Autoinjectors, Implants, Inhalers, Prefilled Syringes, On Body Deliver Systems and more.
- Hands-on document authoring: 510(k) eSTAR, EU MDR Technical Documentation, QMSR procedures.
- Experience preparing for and participating in FDA Pre-Submission interactions, Notified Body meetings and cross-functional regulatory discussions with LATAM authorities (ANVISA, COFEPRIS, INVIMA
- Bilingual EN/ES — extends seamlessly into LATAM and Spain.