Director of Quality Assurance and Regulatory Affairs

Job Overview We are seeking a dynamic and experienced Director of Quality Assurance and Regulatory Affairs to lead our quality management systems and ensure compliance with all relevant regulations. In this pivotal role, you will oversee the development, implementation, and continuous improvement of quality and regulatory processes across our CGMP manufacturing operations. Your leadership will drive excellence in product quality, safety, and regulatory adherence, fostering a culture of compliance and innovation. This position offers an exciting opportunity to shape our quality strategy, influence regulatory submissions, and uphold the highest standards in our industry. Responsibilities Develop, implement, and maintain comprehensive quality management systems aligned with

ISO 13485, ISO 9001, CGMP

(Current Good Manufacturing Practices), and other applicable standards. Lead regulatory affairs activities including preparation for FDA submissions, ensuring compliance with FDA regulations and other global regulatory requirements. Oversee all aspects of quality assurance, including quality control, inspections, audits, and validation processes to guarantee product safety and efficacy. Conduct regular internal and external quality audits to identify areas for improvement and ensure adherence to established standards. Manage the implementation of HACCP (Hazard Analysis Critical Control Point) plans to ensure food safety where applicable. Collaborate with manufacturing teams to establish robust quality systems that support efficient production while maintaining compliance. Lead investigations into quality issues or deviations, analyzing root causes and implementing corrective actions promptly. Provide strategic guidance on quality risk management and ensure ongoing training for staff on quality policies and procedures. Stay current with evolving regulatory landscapes and industry best practices to proactively adapt our quality systems accordingly. Requirements Proven experience in leading Quality Assurance and Regulatory Affairs within a manufacturing environment, preferably in medical devices or pharmaceuticals. Deep knowledge of

ISO 13485

(Medical Devices), FDA regulations (21 CFR Part 820), HACCP principles, CGMP standards, and

ISO 9001

Quality Management Systems. Demonstrated success in managing quality audits, inspections, validation activities, and regulatory submissions. Strong project management skills with the ability to coordinate multiple initiatives simultaneously. Excellent analysis skills to interpret data trends, identify issues, and implement effective solutions swiftly. Exceptional leadership capabilities with a focus on fostering a culture of continuous improvement and compliance. Effective communication skills for collaborating across departments and presenting complex information clearly. Join us as we uphold the highest standards of quality while driving innovation forward! This role is ideal for a proactive leader passionate about ensuring product excellence through rigorous quality systems and regulatory expertise. We are committed to supporting your growth as you help shape the future of our industry!

Pay:

$100,000.00 - $150,000.00 per year

Benefits:

401(k) Health insurance Paid time off

Work Location:

In person