Senior Regulatory Affairs Specialist Cincinnati, OH, USA * Mason, OH, USA * Minneapolis, MN, USA * Minnetonka, MN, USA Req #1876 Monday, January 8, 2024 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. POSITION SUMMARY: The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government and local regulatory requirements where AtriCure 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 and continuity. 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. ESSENTIAL FUNCTIONS OF THE POSITION: Develop Regulatory Strategies for new or modified products and assist on project planning. 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. Maintain Regulatory oversight of product specific non-conformance evaluations. 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. Support inspections by FDA, notified body, and other regulatory agencies. Monitor and provide management with impact of changes in the Regulatory environment. Plan, 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 knowledge base on existing and emerging regulations, standards, and guidance documents and apply them to change control assessment and approvals. Independently manage multiple projects, department initiatives, and day-to-day tasks. Demonstrate strong w rking knowledge of clinical technical concepts and applications related to commercialized products. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: 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 BASIC QUALIFICATIONS: Bachelor's degree required or demonstrated equivalent combination of education, training, and experience. A minimum of 4 years of regulatory affairs working experience, mainly for medical devices. Must have knowledge of U.S. and/or European/International regulations and standards. Experience in preparing regulatory submissions; Experience interacting with FDA and/or other regulatory agencies. Provide examples of past approvals clearances with regulatory agencies. Must demonstrate good technical writing skills; Must work well in team environments; Must demonstrate good communication skills in team setting. Proficiency with Microsoft Office; Proven analytical abilities, Solid understanding of manufacturing and design change control, and an awareness of regulatory trends. Ability to travel 10-15% PREFERRED QUALIFICATIONS: 4-year degree in a technical/scientific discipline. Working experience with cardiac devices, including capital equipment. Experience with medical capital equipment with embedded software and knowledge of electrical device standards, i.e., 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. #LI-RW1 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, 20 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: https://www.atricure.com/benefits 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). Other details Job Family Regulatory Affairs Job Function Regulatory Pay Type Salary Employment Indicator Non Manager Share this job: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.