Director, Regulatory Compliance and Quality Assurance

Director, Regulatory Compliance and Quality AssuranceThe Director, Regulatory Compliance is responsible for working with the Vice President of Regulatory Affairs and Quality Assurance (“RA/QA”) executive management, and cross-functional peers, to define and implement the RA/QA compliance strategy globally. Responsibilities include implementing and managing Verathon’s quality management system to ensure it conforms to the standards and regulatory requirements for our industry and working with internal and external constituents to ensure Verathon products meet the highest applicable standards and regulatory requirements.Principal Responsibilities:* Ensure that Verathon’s Quality Management System establishes and maintains sustainable quality assurance processes and compliance to international regulatory requirements and Verathon procedures. These requirements include but are not limited to International Standards: MDSAP, ISO 13485, FDA Quality Systems Regulations (QSR, 21 CFR Part 820), EU MDD/MDR, UK, CMDCAS, PMDA, NMPA, and the TGA.* Responsible for overall planning and management of quality system to ensure continuous design and development, production, and after-market surveillance of safe and reliable products, consistent with established standards and regulatory requirements.* Responsible for development and execution of Verathon Strategic Deployment Planning initiatives as approved by executive management.* Maintenance and continuous improvement of electronic QMS framework for management of quality system documentation including but not limited to quality system, SAAS and quality system software validation, complaint and vigilance reporting, internal/external audit, and training documents.* Ensure the effectiveness of the Quality System by developing and implementing effective processes and tools to identify, investigate, report, measure, and respond to compliance issues.* Refine and implement Verathon training procedures according to regulatory requirements; develop processes to sustain internal company compliance with ongoing QMS requirements.* Maintain up to date knowledge of applicable Quality System requirements and “best practices.” Advise the executive leadership team on potentially significant changes and risks.* Maintain positive, proactive relationships with regulatory agencies that will allow Verathon to maintain substantial compliance with regulation and to have the freedom to operate, globally, in the marketing and distribution of its products and services.Leadership:* Provide exemplary leadership, oversight and direction. This will include effectively supervising, coaching and training staff and cross-functional team members.* Foster a company and team environment of open and transparent communication by sharing company strategies, priorities and updates.* Provide departmental leadership in the implementation of Lean processes and improvements.* Integrate the needs of the compliance function with the needs of the leadership teams and across the company.* Interface with customers regarding quality and regulatory issues and business development opportunities.Knowledge, Skills, and Abilities:* BS degree in a technology/science related discipline.* Minimum of 15 years of Regulatory/QA experience in the medical device industry or other FDA regulated environment.* Experience submitting medical device license applications for US, Europe and Canada is preferred.* Minimum of 7 years of people management experience in establishing, implementing and maintaining quality systems that meet the requirements of MDSAP, ISO 13485, FDA Quality Systems Regulations (QSR, 21 CFR Part 820), EU MDD/MDR, UK, CMDCAS, PMDA, NMPA, and the TGA.* Experience working in a lean manufacturing environment.* Demonstrated leadership, technical aptitude, and problem solving skills.* Proven experience working directly with domestic and foreign regulatory authorities.* Knowledge of QSR, ISO, CE and QA principles.* Experience managing regulatory processes in Japan, China, India, Brazil, Mexico and the Middle East is a plus.* Proven expertise navigating through FDA requirements and licensing procedures.* Excellent communication skills, including verbal and written.* Ability to handle ambiguity and changing priorities and to propose solutions for resolution.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 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, sexual orientation, gender identity, national origin, age, disability, or any other characteristic protected by law.