Senior 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 nerve ablation to block pain in cardiac and thoracic procedures.

About the Role

The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements. This role prepares and submits regulatory filings, including US device 510(k), PMA Supplements, and international submissions (EU, Canada, Australia, Brazil, Japan, and others) to support business growth. The position serves as the regulatory representative on new product development or line extension projects and provides supervision on post-market product changes to maintain approvals.

Responsibilities

• Prepare written regulatory strategies for new product development and sustaining projects.
• Prepare US submissions, including 510(k) regulatory applications, PMA supplements, and 510(k) letters to file to secure or maintain marketing approvals.
• Prepare EU, Canada, Australia, Brazilian, Japanese, and other international submissions or notifications of change as necessary.
• Represent Regulatory Affairs as a core team member on new product development projects to drive innovation and support the Design Control process.
• Provide regulatory support for risk management activities and clinical evaluation.
• Develop regulatory strategies for new or modified products and assist in project planning.
• Act as the regulatory liaison with key agency stakeholders, including FDA, EU Notified Body, Health Canada, and other government agencies, to facilitate timely and favorable review of submissions and pre-submission activities.
• Collaborate with regional regulatory personnel to assess and document the global impact of product changes on registrations and licenses.
• Assist in the development and maintenance of regulatory operational practices.
• Support inspections and audits by FDA, notified bodies, and other regulatory agencies.
• Monitor and provide management with updates on changes in the regulatory environment.
• Conduct reviews and provide input on technical documentation, including test reports across disciplines such as sterilization, biocompatibility, and electrical safety.
• Plan, coordinate, and compile submissions with minimal review and sign-off responsibility.
• Maintain a strong working knowledge of global laws, regulations, guidelines, and standards related to commercialization and post-market surveillance.
• Stay current on existing and emerging regulations, standards, and guidance documents, applying them to change control sign-offs.
• Independently manage multiple projects, department initiatives, and day-to-day tasks.
• Demonstrate a strong working knowledge of clinical technical concepts and applications related to commercialized products.
• Perform additional duties as assigned, including coordinating projects, tracking milestones, and communicating progress to stakeholders.

Requirements

• Bachelor’s degree required or demonstrated equivalent combination of education, training, and experience.
• A minimum of 4 years of regulatory affairs experience, primarily for medical devices.
• Knowledge of U.S. and/or European/International regulations and standards.
• Experience preparing regulatory submissions and interacting with FDA and/or other regulatory agencies.
• Examples of past approvals/clearances with regulatory agencies.
• Strong technical writing skills and ability to work well in team environments.
• Proficient in Microsoft Office; proven analytical abilities.
• Solid understanding of manufacturing and change control, with awareness of regulatory trends.
• Ability to travel 10-15%.
• Regular and predictable work performance; ability to work under fast-paced conditions.
• Ability to make decisions, use good judgment, prioritize duties, and multitask.

Preferred Qualifications

• 4-year degree in a technical or scientific discipline.
• Working experience with cardiac devices, including capital equipment.
• Experience with medical capital equipment with embedded software and knowledge of electrical device standards (e.g., Electrical Safety IEC 60601-1 and EMC).

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.

Pay

Minnesota pay range: $106,000—$130,000 USD.

Benefits

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