Job Description

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 eligible for Verathon’s annual bonus plan based on company and individual performance.

Verathon provides a competitive benefits package including medical, dental, vision, basic life insurance, paid holidays, paid time off and a 401(k) matching plan. For more information, please visit our complete Benefits Summary at

EEO

Research shows that women and underrepresented groups tend to apply to jobs only when they check every box on a job posting. If you’re currently reading this and hesitating to click “Apply” for that reason, we encourage you to go for it! Even if you are not a match for this role, we may have another opportunity that may be a great fit.

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.

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