Senior Regulatory Affairs Specialist Location US-Bothell ID 2024-1173 Category Quality Assurance/Regulatory Affairs Position Type Full-Time Work Model Hybrid Company Overview Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company's BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com. Overview Verathon is looking for a Senior Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in Bothell, WA. This is a site based role. The Senior Regulatory Affairs Specialist is an individual contributor responsible for creating and submitting 510(k) applications, including coordinating any pre-submissions and requests for additional information to obtain clearance. Responsibilities Serve as a core team member in cross-functional new product development teams, leading the development and execution of regulatory strategies in alignment with business objectives and regulatory requirements. Plan, develop, prepare, and obtain timely approval for product submissions, with focus on US FDA 510(k) applications. Ensure compliance with all applicable regulatory requirements governing Verathon, Inc. products, with focus on US FDA. Train and mentor junior regulatory affairs team members. Provide regulatory advice for product design, manufacturing, enhancements, marketing advertising and promotional materials. Ensure compliance with internal procedures, applicable regulations, guidelines, local country registration requirements, with emphasis on FDA's Quality System Regulation for Design Control and labeling requirements. Provide clear and consistent regulatory guidance to facilitate timely delivery of leading-edge products and services to Verathon's customers. Qualifications Capable, confident individual contributor with 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience Working knowledge of all FDA submission requirements, including 510(k), Q-Submission, and associated guidance documents. Demonstrated experience in submitting and obtaining clearance with US FDA. Knowledgeable and skilled core team regulatory affairs representative to ensure regulatory requirements are fulfilled and adequate. Subject Matter Expert in design dossiers and design history file content to ensure design documentation is adequate to support regulatory submissions. Possess excellent situational influencing skills with ability to work effectively in cross-functional teams with R&D, quality, marketing, manufacturing, clinical, and other project team functions. Must have exceptional writing, verbal, and people skills with internal and external stakeholders. Maintain positive, collaborative relationships with all regulatory agencies. Salary range - $112,964 - $154,901 (Compensation will vary based on skills, experience and location. If this position is filled outside the Seattle WA metro area, this salary range will vary depending on the specific hiring location.) Full-time non-sales employees are eligible for Verathon's annual b