Hiring: Senior Regulatory Affairs Specialist Company: AtriCure, Inc. Location: Minnetonka, MN Job Posted Time: 2026-09-16 11:45:33 Employment Type: Contract / Hybrid Target Skills & Keywords : Embedded Systems, Microsoft Office, Risk Management About the job Experience: •4 years of regulatory affairs working experience, mainly for medical devices. Required Skills: •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 •Partner cross-functionally with regional regulatory personnel on assessing and documenting the global impact of product change on product registration and license globally 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. •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 •4-year degree in a technical/scientific discipline •Working experience with cardiac devices, including capital equipment •Demonstrated capacity to regularly walk, sit, or stand as needed •Demonstrated capacity to occasionally bend and push/pull as needed •Demonstrated capacity to pass pre-employment drug screen and background check Compensation: •$106,000 - $130,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!