What are the responsibilities and job description for the Regulatory Co-op Fall 2026 position at AtriCure?
POSITION SUMMARY:
The Regulatory Affairs Co-op is intended to support the Regulatory team by assisting with day-to-day tasks and regulatory submissions to the FDA. The Co-Op will be responsible for helping with the organization of documentation and other carious tasks for the deoartment. In addition to calendar management, the individual may perform duties such as coordination of meetings, filing expense reports, and working on special projects. This role may require handling of highly confidential and sensitive information.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Assists with preparation of 510(k)'s, PMA's, and other regulatory submissions
- Provides support and documentation to international partners in support of international registrations of medical devices
- Maintains internal documentation of domestic and international regulatory approvals
- Creates, edits, and develops visual presentations as needed
- Attends team meetings and other project meetings as necessary
- Completes other tasks and projects as assigned by members of the Regulatory department
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgment
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
- Additional duties as assigned
BASIC QUALIFICATIONS:
- High School Diploma or Equivalent
- Pursuing a Bachelor's degree in Biomedical or Chemical engineering, Business or a Science
- Have a strong interest in Regulatory Affairs at a Medical Device company
- Computer/data entry Skills
- Verbal Communication Skills
- Proficient in Microsoft Office
- Strong Organizational Skills
PREFERRED QUALIFICATIONS:
- Team oriented
- Able to effectively manage and prioritize multiple projects
OTHER REQUIREMENTS:
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Occasionally lift up to 25 pounds
- Ability to pass pre-employment drug screen and background check
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AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits.
AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
You may access our global privacy policy here: https://www.atricure.com/privacy
Benefits:
Maternity & Paternity Leave, Health Insurance, 401K Plan