Regulatory Affairs Specialist II

JOB REQUIREMENTS: Help us change lives At Exact Sciences, we'rehelpingchange how the world prevents, detects and guides treatment forcancer. We give patients and clinicians the clarity needed to makeconfident decisions when they matter most. Join our team to find apurpose-driven career, an inclusive culture, and robust benefits tosupport your life while you're working to help others. PositionOverview The Regulatory Affairs Specialist II is the primary RegulatoryAffairs representative and subject matter expert (SME) on project teams.This position leads the filing and retention and/or writing of files,and obtains approvals for domestic and international regulatorysubmissions. The Regulatory Affairs Specialist II defines the regulatorystrategy for assigned projects, including new product development,product changes, and manufacturing improvement initiatives. This is thelead role in creating, developing, and implementing global regulatoryaffairs procedures and educating others on global regulatoryexpectations and requirements. Essential Duties Include but are notlimited to the following: Lead, participate, and support the preparationand maintenance of regulatory submissions and other premarketregistration activities to acquire appropriate commercial distributionapprovals and/or clearances. Determine and document appropriateregulatory strategies for proposed new products, sustaining engineeringactivities and initiates necessary activities by working with projectteams and regulatory management, as needed. Control and maintainregulatory records. Represent Regulatory Affairs on various projectteams, by attending team meetings and providing the required regulatoryplans, procedures, and pertinent decisions. Confer with other RegulatoryAffairs subject matter experts regarding regulatory requirements of newproduct designs and/or changes to existing designs. Review and approvenew documents and product changes for regulatory compliance, determiningif registration activities are required. Review technical publications,articles, and abstracts to stay abreast of regulatory and technicaldevelopments in the industry and contribute to and/or leads internalcontinuing education activities to support regulatory knowledge sharing.Review and approve product labeling and marketing material. Initiate newpackage inserts and other required product labeling in alignment withregistration strategies. Demonstrate continuous pursuit... For fullinfo follow application link. We are an equal employment opportunityemployer. All qualified applicants will receive consideration foremployment without regard to age, color, creed, disability, genderidentity, national origin, protected veteran status, race, religion,sex, sexual orientation, and any other status protected by applicablelocal, state or federal law. Applicable portions of the Company'saffirmative action program are available to any applicant or employeefor inspection upon request. APPLICATION INSTRUCTIONS: ApplyOnline: ipc.us/t/44B3A8B549544966

Created: 2026-03-16