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© All Rights Reserved. ApplyBlast.com
Criterion Edge
The Senior Regulatory Consultant provides advanced regulatory expertise and strategic guidance for complex compliance matters, leading risk-based decision-making and cross-functional coordination. This role involves developing regulatory strategies, overseeing standards management, and supporting international submissions while ensuring alignment with quality management systems. The position requires interpreting FDA, EU MDR/IVDR, and ISO requirements to translate them into practical business solutions and mitigate regulatory risks.
Headquarters
San Luis Obispo, California, United States
Company Size
11-50 employees
Criterion Edge is a regulatory writing consultancy that provides best-in-class regulatory writing services for the medical device, biopharma/pharma, and in‑vitro diagnostic industries. They prepare submission‑ready regulatory and clinical documents—such as regulatory submissions, clinical study reports, labeling, and other compliance materials—to help clients meet agency requirements. Branded “The Regulatory Writing Experts,” Criterion Edge combines scientific and regulatory knowledge to improve clarity, consistency, and the efficiency of the approval process. They work with sponsors and manufacturers to translate complex data into clear, compliant regulatory communications.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
View leadership team, funding history,
and employee contacts for Criterion Edge.
Criterion Edge didn’t post a salary, so this is our estimate from similar listings.
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