Regulatory Affairs Specialist
Exact Sciences
full-time
Posted on:
Location Type: Hybrid
Location: Madison • California • Wisconsin • United States
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Salary
💰 $64,000 - $105,000 per year
About the role
- Support the operational execution and maintenance of regulatory activities across the product lifecycle, including pre‑market and post‑market regulatory operations.
- Coordinate and support regulatory submissions and registrations by compiling, formatting, publishing, and submitting regulatory documentation in accordance with applicable regulatory requirements and internal procedures.
- Perform regulatory publishing activities, including preparation and submission of electronic submissions (eSTAR, eCopy, and other electronic formats), ensuring technical compliance and completeness.
- Control, maintain, and archive regulatory records to ensure accuracy, traceability, and inspection readiness.
- Manage and maintain regulatory data within regulatory information management (RIM) and related systems, ensuring data integrity and alignment with regulatory activities.
- Support implementation, configuration, validation, and ongoing administration of regulatory systems and tools, including participation in system enhancements and process improvements.
- Coordinate regulatory workflows and routing processes to support document review, approval, and traceability.
- Support state licensing and renewal activities by preparing, submitting, and maintaining licensing applications and associated documentation.
- Maintain facility registrations and listings with regulatory authorities, including updates related to new, modified, or existing facilities.
- Support UDI management activities, including coordination of device identifiers, database updates, and alignment with labeling and regulatory records.
- Coordinate and track regulatory contracts and agreements, including execution status, renewals, and associated documentation.
- Collaborate with global Regulatory Affairs, Quality, Labeling, Legal, and cross‑functional partners to ensure regulatory operational activities are executed accurately and efficiently.
Requirements
- Bachelor’s degree in Physical or Life Sciences; or a High School Diploma/ General Education Degree (GED) and 4 years of relevant career experience in lieu of Bachelor’s degree
- 2+ years relevant experience in a regulated pharmaceutical or medical device environment
- Basic computer skills to include Internet navigation, Email usage, and word processing
- Proficient in Microsoft Office
- Authorization to work in the United States without sponsorship
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Benefits
- paid time off (including days for vacation, holidays, volunteering, and personal time)
- paid leave for parents and caregivers
- a retirement savings plan
- wellness support
- health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsregulatory documentationregulatory publishingelectronic submissionsdata integrityregulatory information managementsystem enhancementsUDI managementlicensing applicationsregulatory contracts
Soft Skills
collaborationcoordinationattention to detailorganizational skillscommunication skills