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Compliance Specialist II Location US-Bothell ID 2024-1244 Category Quality Assurance/Regulatory Affairs Position Type Full-Time Work Model Hybrid 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 Regulatory Compliance Specialist to become the newest member of our QA/RA Team located in Bothell, WA. The Regulatory Compliance Specialist is responsible for assuring the Quality Management System is maintained in a state of readiness to applicable regulations and directives such as FDA 21CFR820; ISO 13485; EU Medical Device Regulations (MDR); Canada Medical Device Regulation (CMDR); Australia Therapeutic Goods Act (TGA); Brazil National Health Surveillance Agency (ANVISA); Japan Pharmaceutical Affairs Law (JPAL); and to corporate standards as applicable. Responsibilities * Perform internal audits to determine compliance with Quality Management System standards, policies, and procedures, as well as regulatory and customer requirements under the direction of the Sr. RC Specialist * Assist the Sr. RC Specialist in generating audit reports, tracking responses, recommending corrective action plans, and verifying implementation effectiveness of QMS corrective and preventive actions * Prepare and/or coordinate regulatory field action assessments (e.g. Health Hazard Evaluations) following established procedures * Provide support for FDA and other governmental or ISO Notified Body inspections, including pre- and post-inspection support * Assist with corrective action and remediation plans, as necessary under the direction of the Sr. RC Specialist * Investigate and develop solutions to procedure and process-related issues * Consult with management and cross-functional partners to help formulate and implement proactive regulatory compliance strategies and controls * Participate and lead project teams to improve processes at both local and global levels * Assist in the execution and distribution of standard metric reports, preparation of compliance input for management reviews, maintains company compliance scorecard and related documentation Qualifications * Bachelor's Degree in a Scientific or Engineering field or equivalent work experience * 2+ years' experience in a Food and Drug Administration or equivalently regulated environment * Knowledge of QSRs, ISO 13485, MDR, CMDR, TGA, and JPAL requirements is required * Certified Lead Auditor strongly preferred (ASQ CQA) * Knowledge of Design Controls and Sterilization preferred * Experience supporting external audits such as FDA, Notified Body, or customer audits preferred * Able to complete regulatory reports and provide written correspondence to internal and external customers including regulatory bodies * Must have excellent oral and written communication skills. Must have the ability to handle confidential data. * Experience or training in Process Excellence and Six Sigma tools and methodologies preferred * Must be a critical thinker, detaile