MAY ESCALONA
Expert Regulatory Affairs & Project Manager Consultant
Highly accomplished Regulatory Affairs and Project Management professional with over 15 years of extensive experience in the medical device and pharmaceutical industries. Proven expertise in driving global regulatory submissions (IND, NDA, BLA, MAA), EU MDR compliance, and comprehensive gap assessments. Adept at leading high-performing teams, managing complex projects from initiation to completion...
Experience: 15+ years
Submissions: 6 510(k), 3 De Novo, 3 PMA
Expertise & Specializations
Regulatory Pathways
Device Specialties
Regions Served
MAY ESCALONA provides regulatory consulting services to clients in:
Credentials & Recognition
Certifications
Project Management Institute
Professional Experience
Enterprise experience
Executive Summary
Professional Overview
Highly accomplished Regulatory Affairs and Project Management professional with over 15 years of extensive experience in the medical device and pharmaceutical industries. Proven expertise in driving global regulatory submissions (IND, NDA, BLA, MAA), EU MDR compliance, and comprehensive gap assessme...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
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, LATAM, APAC
- Background: 15+ years of regulatory experience.
Cruxi view
With 15 years of extensive experience, May Escalona offers a rare and powerful combination of deep global regulatory affairs expertise and certified project management excellence. Her background in large medtech provides a strategic advantage, ensuring robust compliance strategies for companies of all sizes. She demonstrates proven success across the full spectrum of FDA submissions, including high-stakes PMAs and De Novos, and specializes in both traditional (Orthopedic, Cardiovascular) and cutting-edge technologies like SaMD, AI/ML, and wearables. May's unique value lies in her ability to not only devise regulatory strategy but also to execute it flawlessly, leveraging her PMP and Lean Six Sigma credentials to drive complex projects to completion on time and within budget, making her an invaluable asset for any medtech innovator.
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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