Regulatory Affairs Specialist Jobs

Regulatory Affairs Specialist - Verathon®

Verathon® is looking for a Regulatory Affairs Specialist to become the newest member of our QA/RA Team located in Bothell, WA.

The Regulatory Affairs Specialist is responsible for international product registrations. Assists with internal audits, regulatory and customer audits.

Principal Responsibilities:

• Develop and compile documentation in support of new registrations
• Prepare and submit international distribution registration dossiers and licensing requirements by managing certifications and licenses for International customers Research and analyze government requirements
• Manage regulatory release authorization process
• Conduct, compile and develop documentation in support of international distribution
• Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies
• Support 510(k) submission process as directed
• Assist and participate with international and quality systems and regulatory projects
• Create, organize, and maintain international data repository for all submitted quality and customer documents
• Assist customers and regulatory audits as required
• Interact with internal and external customers and regulatory bodies

Knowledge, Skills, and Abilities:

• Experience working in an FDA regulated company for medical device or pharma is preferred
• BS or BA in a related scientific or technical discipline
• 2+ years’ experience in quality assurance or regulatory affairs is preferred
• Able to manage time effectively
• Good communicator both written and verbal
• Proficiency in Microsoft Office applications
• Previous experience in a position that required multi-department interactions

If you’re currently reading this and hesitating to click “Apply” because you don’t check all the boxes, we encourage you to go for it! A true passion and excitement for making an impact is just as important to us as work experience.

Salary range - $89,500-$138,600 (Compensation will vary based on skills, experience and location. The salary range for this position 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.

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.