Temporary Regulatory Affairs Specialist

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 Specialist position will include coordinating and maintaining promotional and commercial material review processes by interacting with marketing and clinical training functional departments.

The Regulatory Affairs Specialist is responsible for supporting material review workflows, maintaining documentation and tracking systems, and ensuring timely communication between requestors and reviewers.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Triage marketing and training material for regulatory review and compliance
• Coordinate review requests by gathering required information from internal stakeholders and routing materials to appropriate reviewers
• Track review activities, feedback, approvals, and changes using Excel and other documentation tools
• Assist with conducting weekly material review meetings
• Assist with promotional and commercial material storage and document maintenance
• Prepare and distribute communications regarding review status, requests, and required follow-up actions
• Support electronic documentation and signature processes using approved company systems
• Independently manage day-to-day tasks

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions and manage changing priorities
• Ability to successfully work with others
• Strong attention to detail and organizational skills
• Ability to communicate effectively with cross-functional teams

BASIC QUALIFICATIONS:

• Computer and data entry skills
• Proficiency with Microsoft Excel and other Microsoft Office applications
• Written and verbal communication skills
• Strong organizational and documentation skills
• Ability to manage multiple tasks and maintain accurate records

PREFERRED QUALIFICATIONS:

• Previous experience in an administrative, coordinator, data entry, documentation, or support role
• Experience using electronic signature platforms (Adobe Acrobat Sign, DocuSign, or similar)
• Experience supporting review, approval, or workflow processes
• Experience in a regulated industry, medical device industry, or medical environment
• Familiarity with Microsoft Forms

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• 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: .

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).

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