Regulatory Affairs Specialist - Labeling and Operations

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Position Overview

The Regulatory Affairs Specialist - Labeling & Operations supports regulatory compliance through the execution and oversight of regulatory labeling and regulatory operations activities. This role collaborates across functions to ensure product labeling meets global regulatory requirements and that submission documents are formatted, tracked, and archived according to applicable standards. The role assists with the maintenance of regulatory systems, databases, and procedures to support the company's regulatory strategies and compliance obligations.

Essential Duties

Include but are not limited to the following:

• Participate or support the preparation and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution approvals and/or clearances.
• Represent Regulatory Affairs on various project teams by attending team meetings and providing the required plans, procedures and regulatory decisions.
• Confer with other Regulatory Affairs subject matter experts about the regulatory requirements of new product designs and/or changes to existing designs.
• Support development, review, and approval of labeling content and packaging, including Instructions for Use (IFUs), cartons, and labels in accordance with global regulatory requirements.
• Coordinate cross-functional reviews of labeling content and ensure timely implementation of labeling updates.
• Maintain labeling change control documentation, systems, and records.
• Support regulatory operations functions, including document formatting, tracking, and submission readiness across systems and regulatory platforms.
• Manage regulatory archives consistent with regulatory and quality policies.
• Assist with publishing documents for global submissions using electronic submission tools (e.g., eSTAR, ESG).
• Maintain data integrity in regulatory systems including registration tracking tools and document repositories.
• Collaborate with cross-functional teams and stakeholders to ensure accuracy and consistency of regulated content and documentation.
• Stay current on global regulatory requirements related to labeling and operations and apply learnings to improve internal procedures.
• Support and comply with the company's Quality Management System policies and procedures.
• Review and approve product labeling and marketing material. Initiate new package inserts and other required product labeling.
• Demonstrate continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations and policies applying to medical devices including, PMAs, 510(k)s, labeling and promotional materials, global registration, and technical writing.
• 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 lift up to 10 pounds for approximately 10% of a typical working day.
• 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 with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• 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.

Preferred Qualifications

• Experience with labeling content development or change control documentation.
• Familiarity with regulatory systems and tools.
• Knowledge of UDI requirements, GUDID submissions, and global labeling regulations.
• Experience with electronic submissions or technical formatting for regulatory documents.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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