Earn a Master's in Pharmaceutical Bioengineering part-time, in the evenings at UW. Learn more.
Earn a Master's in Biomedical Regulatory Affairs part-time, in the evenings at UW. Learn more.
Senior Regulatory Compliance Manager
Verathon® is looking for a Regulatory Compliance Manager to become the newest member of our Quality Assurance Team located in our Bothell, WA headquarters. The Regulatory Compliance Manager is responsible for providing oversight of the global complaint reporting and corrective action processes. The Regulatory Compliance Manager will ensure the effectiveness of the Quality System by developing and implementing effective processes to identify, investigate,
report, measure, and respond to compliance issues through development and consistent implementation of tools, training programs, and actionable metrics.
- Corporate Quality Systems process owner for the global corrective and preventive action process.
- Develop effective Corrective Action Board presentations and maintain meeting minutes.
- Facilitate discussions with CAPA owners to drive documentation and completion of investigations, root-cause analyses, and impact analyses.
- Analyze trends to monitor the effectiveness of the CAPA process and drive remediation for improvement.
- Monitor investigations and approvals to ensure that all the required information is captured and documented with relation to events.
- Provide training and system awareness on a global level.
- Corporate Quality Systems process owner for customer complaint reporting process.
- Manage the Verathon complaint handling unit (CHU) in processing and reporting of product complaints.
- Assess resource needs for the coordination of complaint intake, evaluation, investigation and reporting activities.
- Guide the CHU in the determination of potentially critical complaints (PCC) for Medical Device Reporting (MDR), Mandatory Problem Report (MPR), and Vigilance requirements.
- Escalate issues that may require corrective action.
- Evaluate quality data for product trending, preventive and corrective actions.
- Provide training to Verathon Customer Care and CHU personnel in complaint recognition, investigation and reporting.
- Participate in establishing strategic direction for quality system activities that are aligned with business and quality initiatives and in compliance with all regulatory requirements.
- Develop, implement, and maintain procedures and work instructions to support the administration of the quality system.
- Maintain current knowledge of, and compliance with, the full range of related quality systems, technology, regulatory requirements, and related policies and procedures.
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
- Review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
Knowledge, Skills, and Abilities:
- 4-year degree (Engineering preferred).
- 5-8 years of CAPA experience, specifically related to 21CFR 820.100 preferred.
- Expert knowledge of the US Quality System Regulations and ISO 13485.
- Strong collaboration skills across business units.
- Strong statistical and root cause analysis background.
- Excellent written & verbal communication skills.
- Strong training skills.
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 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, and has international subsidiaries in Canada, Europe and Asia. 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, sex, national origin, age, disability, or any other characteristic protected by law.
Verathon Medical is an Equal Opportunity Employer