Regulatory Affairs Specialist

About the Company

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions, affecting more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons globally use AtriCure technologies for Afib treatment and reducing related complications. The company’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for persistent Afib treatment. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. The Hybrid AF™ Therapy offers a minimally invasive, lasting solution for long-standing persistent Afib patients. The cryoICE cryoSPHERE® probe is cleared for temporary peripheral nerve ablation to block pain in cardiac and thoracic procedures.

AtriCure fosters a culture of inclusion, embracing diverse experiences and individuals, and provides programs and resources to support equitable professional and personal contributions.

About the Role

This position will originate appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. It involves maintaining internal documentation of approvals and handling requests from international distributors and customers. The role requires compliance with the Quality System Manual procedures and adherence to safety, health, and environmental policies.

Responsibilities

• Support global regulatory pre-market applications for geographies including Taiwan, Singapore, Australia, Brazil, Korea, UAE, EU, UK, U.S., Japan, and Canada. Submission support may include IDEs, PMA submissions and supplements, 510(k) for the U.S., EU Technical Documentation, and/or Japan Shonin.
• Support global regulatory post-market activities, such as updating 510(k) letters to file, Technical Files, Design Dossiers annually, preparing and submitting product renewals, and annual/post-approval reports.
• Support product marketing in additional geographies with international regulatory submissions, product renewals, tender bids, and fulfilling custom requirements.
• Request Certificates to Foreign Government and Free Sale Certificates as new products are approved.
• Obtain notarization and legalization of documents as required.
• Maintain, update, and track open regulatory requests, providing periodic status updates.
• Review product and manufacturing changes for compliance with applicable regulations (Change Control).
• Work with Regulatory Affairs staff, engineers, and technical experts to resolve potential regulatory issues, deficiencies, and questions from agencies.
• Maintain submission correspondence files and other regulatory files in a complete manner.
• Maintain regulatory files for product compliance.
• Perform other related duties in support of regulatory activities.
• Assist in interacting with reviewers from regulatory agencies on specific projects.
• Provide support during internal and external audits.
• Maintain current knowledge of worldwide regulatory requirements.
• Regular and predictable work performance in a fast-paced environment.
• Ability to make decisions, use good judgment, prioritize duties, and multitask.
• Successfully work with others and manage multiple projects.

Requirements

• Bachelor’s degree in a technical/scientific/life science discipline required, or 3+ years of Regulatory experience in the medical device industry.
• Proficient in Microsoft Office programs.
• Strong written and verbal communication skills.
• Problem-solving and troubleshooting experience.

Qualifications

• Minimum of 2 years of experience in the medical device industry.
• Basic knowledge of U.S. and/or European/International regulations and standards.
• Strong understanding of documentation within a quality management system.
• Team-oriented with the ability to effectively manage and prioritize multiple projects.
• General knowledge of medical terminology.

Other Requirements

• Ability to regularly walk, sit, or stand as needed.
• Ability to occasionally bend and push/pull as needed.
• Ability to pass pre-employment drug screen and background check.
• Occasional travel may be required.
• Hybrid environment with remote possibilities.
• Travel responsibilities to AtriCure facilities for team functions and activities when needed.

Pay

MN Hiring Range: $85,000–104,000

Benefits

• Medical & Dental coverage beginning day 1 of employment.
• 401K with company match.
• 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads.
• Volunteer Time Off.
• Pet Insurance.
• Full access to on-site fitness center and cafeteria for corporate-based employees.