The Director of Quality Assurance and Regulatory Affairs position at Interrad Medical will be a key person within the organization who leads and ensures compliance to the quality system at Interrad Medical. This position will provide hands on leadership, tactical implementation, follow-up, and documentation that demonstrates that the quality system is incompliance with QSR and ISO 13485 requirements as well as country/region specific requirements.

Responsibilities

• Lead company-wide efforts to maintain and continuously improve the Quality Management System for Interrad Medical to ensure the quality of SecurAcath and other devices and components
• Oversee QMS training for employees
• Ensure compliance with the US FDA quality system requirements, EU MDR regulations, ISO 13485 standards, and other applicable regulations and standards across the globe
• Guide the company’s regulatory strategy
• Manage regulatory audits and inspections from preparation to responses
• Includes Medical Device Single Audit Program (MDSAP)
• Coordinate both internal audits and supplier audits
• Lead risk management activities from assessment to monitoring
• Support supplier quality management activities
• Oversee complaint handling process
• Support product return and failure analysis
• Manage corrective and preventive action process
• Lead post-market surveillance activities including writing and updating PSUR and SSCP reports
• Oversee document controls including the creation, approval, distribution, and retention of documents as well as the records that are produced
• Lead quarterly management review meetings for the company
• Cross-functional collaboration with engineering on product development
• Cross-functional collaboration with engineering on test methods and with operations on inspection methods
• Other duties as assigned

Qualifications

• Bachelor's degree in a relevant discipline; master’s degree preferred.
• Minimum of ten (10) years of experience in both quality and regulatory in medical devices
• Understands FDA regulations, MDR regulations, ISO standards and other applicable global regulatory requirements and standards
• Understands current Good Manufacturing Practices (cGMP)
• Post-market surveillance experience including PSUR and SSCP
• Experience with QMS software; experience with Grand Avenue software is preferred.
• Experience managing regulatory audits and inspections
• ISO 13485 certified internal auditor is preferred