Overview

Verathon is looking for a Director, Regulatory Affairs to become the newest member of our QA/RA Team located in Bothell, WA. This is an onsite position based in our Bothell WA Headquarters. 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 (., 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 eligible for Verathon’s annual bonus plan based on company and individual performance.