Regulatory Affairs Specialist I

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At Exact Sciences were helpingchange 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 youre working to help others.

Position Overview

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 crossfunctional partners to ensure regulatory information is accurate traceable and maintained in a state of inspection readiness in accordance with applicable regulatory requirements.

Essential Duties

Include but are not limited to the following:

• Support the operational execution and maintenance of regulatory activities across the product lifecycle including premarket and postmarket 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 crossfunctional 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 companys 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 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

• Bachelors 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 Bachelors 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

• Bachelors degree in Science or Health related discipline.
• Experience working with regulatory information management (RIM) systems or similar regulatory tracking and document management tools.
• Strong attention to detail with the ability to manage complex regulatory documentation and data accurately.
• Strong organizational and timemanagement skills with the ability to manage multiple priorities and meet deadlines.

Salary Range:

$64000.00 - $105000.00 USD Annual (National)

$74000.00 - $121000.00 USD Annual (California)

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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