Senior Regulatory Affairs Specialist

Position Summary The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government 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. 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. Responsibilities 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 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 sign‑offsn Independently manage multiple projects, department initiatives, and day‑to‑day tasks Demonstrate strong working knowledge of clinical technical concepts and applications related to commercialized products Additional Responsibilities Regular and predictable work performance Ability to work under fast‑paced conditions Ability to make decisions and use good judgement 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 Minimum of 4 years of regulatory affairs working experience, mainly for medical devices 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 Examples of past approvals/clearances with regulatory agencies Good technical writing skill; team and communication skill Proficient with Microsoft Office; analytical abilities; solid understanding of manufacturing and change control; 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 (e.g., 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 Compensation US Pay Range: $106,000 - $130,000 USD. Positions in Minnesota: $106,000 - $130,000 USD. Benefits AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401(k) plus match, 30 days of paid parental leave, 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 EEO & Equal Opportunity AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. AtriCure is an Equal Employment Opportunity / AffReamtive Action employer and provides a drug‑free workplace. 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). #J-18808-Ljbffr Atricure,-Inc