Director, Regulatory Affairs - Verathon®

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.

Principal Responsibilities:

• Ensure compliance with all applicable regulatory or clinical standards governing Verathon, Inc. products
• Prepare and obtain approval for product submissions to FDA and other worldwide regulators for Verathon’s products
• Manage the planning, execution, and reporting of regulated (e.g., FDA, EU, TGA) clinical investigations of Verathon new products, as required
• Lead an internal team of Regulatory Associates and as required, contracted clinical study, medical professionals, or other consultants to achieve department and corporate objectives
• Manage the review and approval of product design, manufacturing and quality assurance changes and marketing advertising and promotional materials to ensure compliance with internal procedures, applicable regulations and guidelines, local country registration requirements, and FDA’s Quality System Design Control and labeling requirements
• Serve as key leadership team member in cross-functional program teams
• Provide clear and consistent regulatory guidance to facilitate timely delivery of leading-edge products and services to Verathon customers

Knowledge, Skills, and Abilities:

• Bachelor’s degree in a related scientific or technical discipline is required; Masters preferred
• 5 years of experience in a Regulatory Affairs management role
• 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 and must thrive 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 with whom Verathon’s products are regulated
• Ability to travel up to 20% of the time including internationally (Amsterdam, British Columbia primarily)
• Ability to grow and develop a talented team to sustain a productive and positive working environment

About Verathon:

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.

Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success. In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Verathon will be based on merit, qualifications, and abilities. Verathon does not discriminate in employment opportunities or practices on the basis of race, color, religion, sexual orientation, gender identity, national origin, age, disability, or any other characteristic protected by law.