Exact Sciences Corporation

Regulatory Affairs Specialist II, Product

Exact Sciences Corporation

2 days ago
Madison, WI
Onsite
Full Time
Senior
0 applicants
Exact Sciences Corporation
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About this role

The Regulatory Affairs Specialist II at Exact Sciences is responsible for leading the filing, retention, and approval of regulatory submissions for medical devices and diagnostics. They define regulatory strategies for new and existing products, ensuring compliance with global requirements, and support internal education on regulatory topics. The role involves collaboration across teams, technical writing, and stakeholder communication.

Skills

Qualifications

BS in Physical or Life Sciences5+ years in regulated medical device or pharmaceutical environment
Exact Sciences Corporation

About Exact Sciences Corporation

exactsciences.com

Industries

Healthcare

Exact Sciences is a leading company dedicated to cancer prevention and early detection through innovative testing solutions. Specializing in molecular diagnostics, the firm provides advanced tests that help identify potential malignancies and guide therapy decisions. Their flagship product, Cologuard, is a non-invasive screening test for colorectal cancer, contributing significantly to patient health management. Exact Sciences aims to enhance patient outcomes by promoting early detection and regular screenings.

About Exact Sciences Corporation

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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