VP of Clinical
Mary Patterson
Clinical operations leader turning regulatory complexity into competitive advantage. Building the systems that keep medtech companies compliant, scalable, and FDA-ready.
Get in Touch4+
Years at Ferguson
500K+
Products Optimized
Millions
of Monthly Users
About
Clinical leadership that moves the needle
I'm the Vice President of Clinical at a high-growth medtech SaaS company, where I lead clinical operations, regulatory strategy, and quality systems from the ground up.
When I stepped into this role, the company was facing an FDA audit that threatened to shut down operations. I built the quality management infrastructure, led the response, and brought us into full compliance — turning a crisis into a foundation for growth.
Since then, I've scaled clinical workflows, established SOPs that hold up under scrutiny, and partnered with engineering and product teams to embed compliance into the product itself. I believe the best clinical leaders don't just react to regulation — they design systems where quality is the default.
Services
What I can do for you.
Regulatory Strategy
Navigating FDA, ISO 13485, and global regulatory frameworks. I build submission-ready documentation and quality systems that accelerate clearance timelines.
Clinical Operations
Designing and scaling clinical workflows, SOPs, and team structures that support rapid growth without sacrificing compliance or quality.
Quality Management Systems
Building QMS frameworks from scratch or remediating existing systems to meet FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements.
Cross-Functional Leadership
Bridging clinical, engineering, and product teams to embed regulatory thinking into the development lifecycle — not bolt it on at the end.
Projects
Recent work.
FDA Audit Remediation & Compliance Turnaround
Led the company through a critical FDA audit that threatened operational shutdown. Built quality management infrastructure from the ground up, established corrective actions, and achieved full compliance — transforming a regulatory crisis into a foundation for sustainable growth.
Clinical Workflow Automation
Partnered with product and engineering to redesign clinical data capture and reporting workflows within the SaaS platform, reducing manual documentation time by 60% while improving audit trail integrity.
Enterprise QMS Build-Out
Designed and implemented a comprehensive quality management system aligned with ISO 13485 and 21 CFR Part 820, including document control, CAPA, supplier management, and management review processes.
Contact
Let's connect
Whether you're navigating a regulatory challenge, scaling clinical operations, or building quality systems for growth — I'd love to hear from you.
Email Mary