Regulatory Affairs Specialist II, Product

Exact Sciences • Madison, WI

18d • $76,000 - $125,000

About The Position

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. Position Overview The Regulatory Affairs Specialist II is the primary Regulatory Affairs 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 regulatory submissions. The Regulatory Affairs Specialist II defines the regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. This is the lead role in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements.

Requirements

• Bachelor’s degree in Physical or Life Sciences or a field as outlined in the essential duties; or a High School Diploma/ General Education Degree (GED) and 4 years of experience in a field as outlined in the essential duties.
• 5+ years experience in a regulated pharmaceutical or medical device environment.
• Working knowledge of CDx tests (if primary focus is companion diagnostics).
• Strong proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Nice To Haves

• Bachelor’s degree in Physical or Life Sciences.
• Experience with process of transition from biomarker assay to marketed CDx product (if primary focus is companion diagnostics).
• Familiarity with adverse event reporting, post-market surveillance, and vigilance requirements.

Responsibilities

• Lead, participate, and support the preparation and maintenance of regulatory submissions and other premarket registration activities to acquire appropriate commercial distribution approvals and/or clearances.
• Determine and document appropriate regulatory strategies for proposed new products, sustaining engineering activities and initiates necessary activities by working with project teams and regulatory management, as needed.
• Control and maintain regulatory records.
• Represent Regulatory Affairs on various project teams, by attending team meetings and providing the required regulatory plans, procedures, and pertinent decisions.
• Confer with other Regulatory Affairs subject matter experts regarding regulatory requirements of new product designs and/or changes to existing designs.
• Review and approve new documents and product changes for regulatory compliance, determining if registration activities are required.
• Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry and contribute to and/or leads internal continuing education activities to support regulatory knowledge sharing.
• Review and approve product labeling and marketing material.
• Initiate new package inserts and other required product labeling in alignment with registration strategies.
• 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 and post-market reporting), labeling and promotional materials, global registration, and technical writing.
• Regularly communicate with external and internal stakeholders regarding regulatory aspects of products.
• Excellent 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.
• Adapt readily to changes in workload, staffing, and scheduling.
• Conduct self in a professional manner with coworkers, management, customers, and others.
• Provide mentorship to more junior team members.
• 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.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• 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 and means to travel between local Exact Sciences locations.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level