AtriCure
Senior Regulatory Affairs Specialist
United States of America · Senior · Contract
Sponsorship not specified$10k-$15kDetected 21 days ago
Embedded SystemsEMI/EMCFDA RegulatoryMedical DevicesCommunicationWritingMicrosoft OfficeRegulatory Affairs
About the role
- Prepare written regulatory strategies for new product development and sustaining projects
- Prepare EU, Canada, Australia, Brazilian, Japanese, and other international submissions or notifications of change when necessary
- 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
Responsibilities
- 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.
- The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business.
- 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
- 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
- Collaborate with regional regulatory personnel on assessing and documenting the global impact of product change on product registration and license globally
- Support inspections by FDA, notified body, and other regulatory agencies
- Maintain current knowledge base on existing and emerging regulations, standards, and guidance documents and apply them to change control sign-offs
Requirements
- 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
- Proven analytical abilities, Solid understanding of manufacturing and change control, and an awareness of regulatory trends
- Ability to travel 10-15%
Nice to have
- 4-year degree in a technical/scientific discipline
- Working experience with cardiac devices, including capital equipment
- Electrical Safety (IEC 60601-1) and EMC
- 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
- For jobs that can work anywhere
- Positions in Minnesota
Skills
- AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions.
- Afib affects more than 33 million people worldwide.
- 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.
- For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
Compensation
- $106,000 - $130,000 USD
Benefits
- https://www.atricure.com/careers-atricure/benefits.
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This listing is sourced directly from AtriCure's careers page and normalized into a canonical job model.