Senior Regulatory Affairs Specialist

Atri Cure, 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 Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure’s Atri Clip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure’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  or follow us on Twitter @Atri Cure.

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 Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where Atri Cure conducts business. This position will prepare and submit submissions, which may include US device 510(k), PMA Supplements, EU, Canada, Australia, Brazilian, Japanese, and other international submissions to support business growth. The position will serve as regulatory representative on selected projects for new product development or line extension and will provide regulatory supervision on post-market product changes to maintain marketing approvals.

• Prepare written regulatory strategies for new product development and sustaining projects
• Prepare US submissions as necessary including 510(k) regulatory applications, PMA supplements for device and manufacturing, drafting 510(k) letters to file to secure/maintain marketing approvals
• Prepare EU, Canada, Australia, Brazilian, Japanese, and other international submissions or notifications of change when necessary
• Represent Regulatory Affairs as core team member of new product development projects to drive innovation and to support Design Control process
• Provide Regulatory support for risk management activities and clinical evaluation
• Develop Regulatory Strategies for new or modified products and assist on project planning
• Act as the Regulatory liaison with key agency stakeholders including FDA, EU Notified Body, Health Canada, and other government agencies on behalf of the organization to facilitate timely and favorable review of submissions and pre-submission activity
• Collaborate with regional regulatory personnel on assessing and documenting the global impact of product change on product registration and license globally
• Assist in development/maintenance of regulatory operational practices
• Supports inspections and audits by FDA, notified body, and other regulatory agencies
• Monitor and provide management with impact of changes in the Regulatory environment
• Conducts reviews and provides input to the development of technical documentation including test reports across multiple disciplines including sterilization, biocompatibility, and electrical safety.
• Plans coordinate and compile submissions with minimal review and with sign-off responsibility
• Demonstrate strong working knowledge of global laws, regulations, guidelines, and standards related to commercialization and post market surveillance
• Maintain current…