Director, Regulatory Affairs & Quality

Company Description

Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information.

Core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere. For more information, please visit

The Director, Regulatory Affairs & Quality is primarily responsible for securing and maintaining regulatory approvals for company products, for providing strategic direction, oversight and alignment with company processes for all Regulatory Affairs and Quality functions and for ensuring company-wide compliance with all global regulatory requirements. This person will provide Quality leadership and support for product development projects and commercialized product programs and collaborate with key suppliers to ensure components and finished products manufactured for Stereotaxis meet quality requirements.

The position will deploy and support processes for effective good vigilance practices, including adverse event reporting and complaint handling as part of the Quality Management System. Must successfully support and deploy Stereotaxis’ quality systems vision and strategy translating these into tangible organizational goals resulting in the effective development and deployment of the division wide Quality System (a worldwide medical event reporting and complaint handling/investigation system for Stereotaxis).

The successful candidate will have the ability to adapt his/her problem‑solving skills to be creative and motivating, especially when working with teams in order to fit the business and quality system together seamlessly while maintaining regulatory compliance.

• Accountable for the overall management of the Regulatory Affairs and Quality function including organization design and implementation, performance management, financial budgeting, financial performance, and execution to meet strategic and operational objectives.
• Work to identify opportunities to streamline quality system processes; successfully build organizational alignment in adopting newly proposed processes.
• Develop strategies and lead activities necessary for new and renewed regulatory global approvals.
• Support preparation and submission of required information and monitor regulatory review progress through appropriate communication with the regulatory agency and/or registration agent.
• Direct accountability for Quality activities to include product testing (QC), product assessment and release (QA), product quality performance management and realization of Quality Agreement. Coordinate independent inspection readiness as defined in Quality agreement.
• Assess and resolve regulatory issues associated with new product development and proposed device changes in close collaboration with other functions.
• Communicate domestic and international submission requirements to internal customers.
• Accountable for product quality management execution to include product test and disposition, change management, discrepancy management, investigation and day‑to‑day CAPA management (including non‑conformance, tracking, trending and closure), product field performance (complaint management) and product performance trending and reporting.
• Interface with external regulatory agencies during audits and inspections;
  Perform role of lead auditor for internal and external quality system audits.
• Must drive continuous improvement with regard to closing compliance gaps, certifying to new standards and maintaining current licenses/certifications. Must support Quality Plan process as an integral part of the Stereotaxis culture along with the business plan. Brings a common language to the quality system across sites, departments, and…