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Senior Principal Regulatory Affairs Specialist

Company: AtriCure
Location: Minnetonka
Posted on: May 15, 2022

Job Description:

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: This position will originate appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will prepare and submit FDA submissions, which may include new PMA submissions, IDE submissions, FDA pre-submissions, device 510(k), PMA Supplements, and EU MDR Technical Documentation to support business growth. The position will serve as regulatory representative on selected projects for clinical, new product development, or line extension, and will provide regulatory supervision on post-market product changes to maintain marketing approvals. Additionally, the position will provide support and training to junior level members of the Regulatory team. ESSENTIAL FUNCTIONS OF THE POSITION: Prepare written regulatory strategies for PMAs, clinical trials, new product development, and sustaining projects Prepare new PMA, IDE, and Technical Documentation for new product market approvals Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing clearances Prepare PMA supplements for device or manufacturing changes Prepare EU, Canada, Australia, Brazilian, Japanese, and other international submissions or notifications of change when necessary Represent Regulatory Affairs as core team member of the RF Capital group for 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 Plans coordinate and compile US regulatory 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 signoffs 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 judgment Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties as assignedBASIC QUALIFICATIONS: Bachelor's degree required or demonstrated equivalent combination of education, training and experience. A minimum of 10 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 writing/authoring PMAs, IDEs, and other new regulatory submissions; Experience interacting with FDA and/or other regulatory agencies Must demonstrate good technical writing skill; Must work will 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 #LI-RW1AtriCure 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, 15 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/benefitsAtriCure 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).PDN-964507d3-f5c6-4aba-a2d1-06e24e4db58f

Keywords: AtriCure, Minnetonka , Senior Principal Regulatory Affairs Specialist, Other , Minnetonka, Minnesota

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