Regulatory Co-op
About The Position
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. 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 department. 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.
Requirements
- 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
Nice To Haves
- Team oriented
- Able to effectively manage and prioritize multiple projects
Responsibilities
- 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
- 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
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What This Job Offers
Career Level
Intern
Education Level
High school or GED
