Director, Regulatory Affairs Location US-WA-Bothell ID 2025-1489 Category Quality Assurance/Regulatory Affairs Position Type Full Time Work Model Onsite 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 Director, Regulatory Affairs to become the newest member of our QA/RA Team located in Bothell, WA. The Director, Regulatory Affairs is responsible for managing regulatory strategies for worldwide device and registration of Verathon products, in accordance with product development and business objectives. Responsibilities * Serve as a key strategic leader responsible for guiding and managing all regulatory aspects of Verathon's products throughout their lifecycle * Ensure compliance with all applicable regulatory and clinical standards governing Verathon, Inc. products distributed globally * Prepare and obtain approval for product submissions to FDA and other worldwide regulators * Manage the planning, execution, and reporting of clinical evaluations of Verathon new products, as required * Lead, mentor, and develop a team of Regulatory Affairs professionals and contracted clinical study, medical professionals, and other consultants * Manage the review and approval of product design, manufacturing and quality assurance changes, as well as marketing advertising and promotional materials to ensure compliance with internal procedures, applicable regulations and guidelines * Provide clear and consistent regulatory guidance to facilitate timely delivery of leading-edge products and services to Verathon customers * Reporting to the VP Quality and Regulatory, serve as a key senior leadership team member Qualifications * Bachelor's degree in a related scientific or technical discipline is required; Masters preferred * 5+ years of experience in a people leadership role * 8+ years experience in regulatory affairs within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology, or healthcare products) * Demonstrated proficiency and knowledge of current medical device Good Manufacturing Practices, FDA 510(k), HC, EU Technical File/Design Dossier, PMDA and TGA product registrations, FDA Advertising and Promotion guidance and FDA IDE/IRB regulated clinical studies * Must possess excellent leadership skills with ability to work highly effectively in cross-functional teams in a dynamic, fast-paced environment. * Must have exceptional writing, verbal, and interpersonal skills with internal and external stakeholders * Must maintain positive, collaborative relationships with all regulatory agencies where Verathon products are distributed * Ability to grow and develop a talented team to sustain a productive and positive working environment Salary range - $185,000 - $241,000 (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range). Full-time employees who are not on a commission plan are elig