Regulatory Affairs Specialist jobs in Seattle, WA

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.

The Senior Regulatory Affairs Specialist is responsible for serving as an individual contributor to the Regulatory Affairs department and will be responsible for the management of product approvals world-wide.

Responsibilities

• Manage regulatory strategies for the worldwide device listing and registration of Verathon products in accordance with product development and business objectives • Ensure compliance with all applicable regulatory or clinical standards governing Verathon, Inc. products• Plan, develop, prepare, and obtain timely approval for product submissions to FDA and other worldwide regulators for Verathon's products• Mentor an internal team of Regulatory associates, 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 • 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

Qualifications

• Capable, confident individual contributor with 10 years of experience and a BA or 8 years of experience and a MS/MBA • Working knowledge of all FDA submission requirements; including 510(k), Q-Submission, IDE/IRB Clinical submissions• Subject Matter Expert in design dossiers and design history file content to ensure design documentation is adequate to support regulatory submissions• Knowledgeable and skilled core team regulatory affairs representative to ensure regulatory requirements are fulfilled and adequate• Must be proficient in all areas of international regulatory requirements, including AU, NZ, China, Japan, EU, EE, and Middle East countries• Oversee registration and distribution tools required to track and streamline world-wide regulatory approvals• Working knowledge of both direct and distributor models needed to support international registrations• Must be familiar with distribution agreements, language requirements; and country specific MOH requirements for new product registrations and on-going renewals• Must possess excellent “situational” 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• Required to maintain positive, collaborative relationships with all regulatory agencies with whom Verathon's products are regulated• Assist with the growth and development of lower-level regulatory affairs professionals to sustain a productive and positive working environment

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 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 https://www.verathon.com/US-HQ-Employee-Benefits-Summary.

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