Exact Sciences

Regulatory Affairs Manager

2 months agoMadison, WI / Remote

Position Overview

The Regulatory Affairs Manager is responsible for independently managing regulatory affairs activities, originating appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements. This position is responsible for developing regulatory strategy, preparing regulatory submissions and obtaining regulatory approvals necessary to introduce new or re-designed products to market.

Essential Duties

include but are not limited to the following:

  • Establishes regulatory strategy for product marketing.
  • Plans, coordinates and compiles regulatory submissions with minimal review.
  • Participates on project teams to provide appropriate information on regulatory issues and obtain information to meet regulation requirements.
  • Acts as the Regulatory Affairs liaison with FDA and other regulatory bodies on behalf of the organization to facilitate timely and favorable review of submissions and issues.
  • Maintains a current knowledge base on existing and emerging regulations, standards and guidance documents.
  • Assists in reviewing new projects to determine the nature and scope of the regulatory involvement.
  • Reviews labeling for compliance with regulations and assures that claims are substantiated.
  • Supports organizational compliance with FDA and international regulations.
  • Creates and maintains Regulatory Affairs SOPs.
  • Highly organized and able to manage multiple projects and deadlines under strict timelines
  • Strong interpersonal skills and verbal communication skills with the ability to listen, articulate and advocate
  • Proven ability to lead and work effectively with and through multi-functional teams to achieve results.
  • Strong leadership and communication skills.
  • Strong decision-making skills.
  • Ability to communicate ideas, opinions and counter arguments in a proactive and professional manner.
  • Excellent oral and written communication skills.
  • Strong attention to detail and recordkeeping skills.
  • 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 use computers daily in an interactive manner for extended periods of time.
  • Ability to frequently and accurately communicate with employees in person, via the telephone or by email.
  • Ability to travel domestically and internationally (< 10%).


Minimum Qualifications

  • Master's degree in physical or life sciences and minimum three years of relevant experience; or a Bachelor's degree in physical or life sciences and 5+ years of relevant experience.
  • 5 years' experience in the device or pharmaceutical industry.
  • 3 years' experience in direct regulatory medical device submission with specific experience preparing 510(k), IDE and PMA submissions.
  • 2+ years' experience in development, interpretation or application experience with standards, guidelines and special controls.
  • Demonstrated experience with automated Quality System software such as Agile® PLM.
  • Strong working knowledge and experience of FDA regulations and/or international registration requirements, with demonstrated success integrating regulatory content into projects.
  • 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

  • 5+ years' experience in a regulated manufacturing environment, preferably in a GMP/QSR and/or ISO 13485 environment.
  • Experience with Project Management principles and practice.
  • Demonstrated experience in Six Sigma techniques.
  • 1+ years' experience in international submission preparation.
  • Supervisor experience is preferred.

Salary Range:
$105,000.00 - $168,000.00

The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms, conditions, and eligibility requirements of the applicable plans.

If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please email hr@exactsciences.com.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.

To view the Right to Work, E-Verify Employer, and Pay Transparency notices refer to this link. These notices inform you of your rights protected by the Office of Federal Contract Compliance Programs (OFCCP).

Client-provided location(s): Madison, WI, USA
Job ID: Exact Sciences-R23-1567

Perks and Benefits

  • Health and Wellness

    • On-Site Gym
    • Fitness Subsidies
    • HSA With Employer Contribution
    • Long-Term Disability
    • Short-Term Disability
    • Life Insurance
    • Vision Insurance
    • Dental Insurance
    • Health Insurance
    • Pet Insurance
    • Virtual Fitness Classes
    • Mental Health Benefits
    • FSA
  • Parental Benefits

    • Adoption Assistance Program
    • Adoption Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Birth Parent or Maternity Leave
  • Work Flexibility

    • Hybrid Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
    • Company Outings
    • Snacks
  • Vacation and Time Off

    • Leave of Absence
    • Personal/Sick Days
    • Paid Holidays
    • Paid Vacation
    • Volunteer Time Off
  • Financial and Retirement

    • Financial Counseling
    • Performance Bonus
    • Stock Purchase Program
    • Company Equity
    • 401(K) With Company Matching
  • Professional Development

    • Access to Online Courses
    • Shadowing Opportunities
    • Mentor Program
    • Promote From Within
    • Tuition Reimbursement
    • Internship Program
  • Diversity and Inclusion

    • Diversity, Equity, and Inclusion Program

Company Videos

Hear directly from employees about what it is like to work at Exact Sciences.