Director, Quality Assurance/Regulatory Affairs

Director, Quality Assurance/Regulatory Affairs Miamisburg, Ohio Commute Time The Quality Assurance/Regulatory Affairs Director will be an experienced quality professional with extensive knowledge of quality management and regulatory affairs. Aerobiotix incorporates ISO 9001, ISO 13485 and FDA 21 CFR 820 quality systems. The individual must have the ability to establish efficient and compliant processes throughout the organization. The ideal candidate must be an individual contributor, while interfacing with C-suite, engineering, product development, document control, sales, and production operations. Located at Dayton, Ohio Headquarters. Key Responsibilities: 1. Establish medical device regulatory strategy to include product labeling, compliance review, 510K claims strategy, and claims substantiation. 2. Establish, develop, and maintain quality assurance procedures required to ensure that the Company’s processes and products are in compliance with applicable FDA, ISO, and EPA quality requirements. 3. Participate in the review of product and design requirements and functional specifications. 4. Supervise Risk Management, CAPA, and FMEAs to ensure compliance with standards and regulations. 5. Supervise preparation for and conducting of regulatory agency inspections. 6. Establish quality assurance and quality control inspection and testing procedures. Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions. 7. Establish and maintain test instrument calibration procedures and maintenance schedules. 8. Identify quality assurance metrics; analyze and report trends to management. 9. Supervise complaint handling and complaint processes in compliance with applicable standards. 10. Serve as Management Representative – understand and perform tasks described within the Quality Management System for Management Representative duties. 11. Review for completeness and adequacy of the Design History Record for all products. 12. Maintain Greenlight Guru eQMS. 13. Manage all Quality/Regulatory personnel. 14. Other tasks as assigned by management. Professional Qualifications and Knowledge Domain 1. Required: Bachelor’s Degree from regionally accredited academic institution with a minimum of 5 years of experience in the medical device industry. 2. Preferred: Foundation in Regulatory Affairs Certification (minimum) or Regulatory Affairs Certification-Device (RAC-Device) (strongly preferred) 3. Bachelor’s Degree with a minimum of 5 years of experience in the medical device industry. 4. Comfort with early-stage, high growth entrepreneurial work environment. 5. Thorough knowledge of ISO 13485 and ISO 9001 Quality Systems Management, as well as knowledge of FDA CFR 21 Part 820 Quality System Regulations for Medical Devices and Good Manufacturing Practices (GMPs). 6. Familiarity with EN 60601, UL/ETL requirements for electrical systems a plus. 7. Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents. 8. Familiarity with international regulatory procedures a plus. 9. Effective problem-solving skills. Demonstrated project management skills and experience. 10. Ability to work in a team minded approach to achieve individual and company success. 11. Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, and Microsoft Office PowerPoint. Excellent verbal and written communication skills. Travel: 5% or Less