AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

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

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

Regulatory Co-op

AtriCure