Associate Medical Writer, In Vitro Diagnostic Regulation (IVDR) Writing Services
Criterion Edge
About this role
An Associate Medical Writer at Criterion Edge specializes in developing and managing regulatory-compliant performance evaluation reports (PER) for in vitro diagnostic (IVD) products, supporting EU IVDR submission requirements. The role involves collaborating with team members to produce high-quality documents, adhering to regulatory standards and project timelines, and applying scientific knowledge to regulatory writing projects.
Skills
About Criterion Edge
criterionedge.comCriterion 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.
About Criterion Edge
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
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
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Salary
$98k – $132k
per year