Regulatory Affairs Specialist

Overview

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

The Regulatory Operations Specialist I supports regulatory compliance by executing and managing operational regulatory activities across the product lifecycle. This role is responsible for enabling efficient regulatory processes through the coordination of regulatory submissions, management of regulatory data and systems, and support of ongoing registrations, licenses, and records. The Regulatory Operations Specialist works closely with Regulatory Affairs and cross‑functional partners to ensure regulatory information is accurate, traceable, and maintained in a state of inspection readiness in accordance with applicable regulatory requirements.

• 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.
• Strong technical writing skills.
• Effective communicator: ability to convey messages in a logical and concise manner. Consistently reinforce regulatory expectations and requirements.
• Exceptional attention to detail.
• Strong organizational skills.
• Independent self-starter; manage time effectively and complete tasks on-time with minimal supervision.
• Flexible and able to self-manage multiple priorities.
• Ability to work effectively in multinational/multicultural environments.
• Adapt readily to changes in workload, staffing, and scheduling.
• Comply with management direction. Seek assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
• Conduct self in a professional manner with coworkers, management, customers, and others.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to work designated schedule.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 75% of a typical working day.
• Ability to grasp with both hands; pinch…