VP of Regulatory & Quality
VP of Regulatory & Quality
Industry
Pathology
Capital
Series C, $72M
Team Size
90
By the Numbers
114
Identified
49
Vetted
7
Introduced
1
Placed
91
Days
The Challenge
In pathology, 510(k) and de novo clearances are table stakes, coupled with a sound quality system. As the company scaled, they needed a leader who would oversee the existing regulatory and quality departments. This individual would be responsible in developing and executing on US and OUS submission strategy for existing and future products.
The Mandate
Attributes
Ideal
Domain expertise
Pathology SaMD
Submission experience
510(k), de novo, CE Mark
Quality expertise
Oversee US + OUS QMS
Additional experience
Compliance, Clinical Trials
FDA / Industry Relationships
Drives difficult FDA convos
Product Comm. & Roadmap
ID’d + led reg roadmaps
Project Management
Exceptional PM / org skillset
Team Management
5+ years managing team
Player / Coach
Hands-on; strategic + tactical
Cross Functional Collab.
Exceptional communicator
Start-up experience
Thrives in startup environ.
Location
Philadelphia
We are very happy with where we landed. [The candidate] has real experience in SaaS medical device and is a real business partner who will develop creative solutions for business challenges for regulatory objectives. In fact, she’s already jumped in and started to make an impact.
CEO
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