Senior Regulatory Affairs Specialist

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 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. ESSENTIAL FUNCTIONS OF THE POSITION: 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 knowledge base on existing and emerging regulations, standards, and guidance documents and apply them to change control sign-offs 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 ESSENTIAL FUNCTIONS OF THE POSITION: 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 Ability to coordinate projects, track milestones and communicate progress to stakeholder 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 skill; Must work well in team environments; Must demonstrate good communication skill in team setting Proficient on programs within Microsoft Office; Proven analytical abilities, Solid understanding of manufacturing and 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, ie. 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 Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in AtriCure’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. 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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 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). Positions in Minnesota $106,000 - $130,000 USD AtriCure has a variety of benefits available for US based employees and their families. Medical & Dental beginning day 1 of employment 401K plus match 30 days of paid Parental Leave maternity leave, for new moms and dads Volunteer Time off Pet Insurance on-site fitness center cafeteria 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: . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. #J-18808-Ljbffr