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Quality and Regulatory Affairs Director
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MED-Fibers, Inc
Chandler, AZ (In Person)
$100,000 Salary, Full-Time
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Job Description
Overview We are seeking a dynamic and highly experienced Quality and Regulatory Affairs Director to lead our quality management systems and ensure compliance with global regulatory standards. This pivotal role involves developing, implementing, and maintaining robust quality assurance and regulatory strategies across manufacturing and product development processes. The ideal candidate will drive continuous improvement initiatives, oversee audits, and ensure our products meet the highest safety, quality, and regulatory standards. Join us to lead our quality excellence journey and make a meaningful impact on product safety and compliance worldwide. Responsibilities Develop, implement, and oversee comprehensive quality management systems aligned with ISO 13485, MDR, CGMP, and other relevant standards to ensure consistent product quality. Lead regulatory compliance efforts by maintaining up-to-date knowledge of FDA and MDR regulations, international standards, and industry best practices; prepare documentation for regulatory submissions. Conduct regular internal and external quality audits to verify adherence to established standards; identify areas for improvement and implement corrective actions. Manage all aspects of quality control, inspection, and assurance processes across manufacturing facilities to uphold product integrity. Collaborate with cross-functional teams—including manufacturing, R&D, supply chain, and legal—to ensure compliance throughout the product lifecycle. Drive continuous improvement initiatives by analyzing quality data, implementing corrective/preventive actions (CAPA), and refining processes to enhance efficiency. Lead training programs to promote a culture of quality awareness among staff; ensure all team members understand regulatory requirements and quality protocols. Requirements Proven experience in leading Quality Assurance (QA), Quality Control (QC), Regulatory Affairs, or related roles within manufacturing environments. Deep knowledge of ISO 13485 and MDR (medical devices), FDA regulations (21 CFR Part 820), HACCP principles, CGMP guidelines, ISO 9001 standards, and related regulatory frameworks. Strong background in conducting quality audits, inspections, and assessments; excellent analysis skills for interpreting complex data sets. Demonstrated project management skills with the ability to lead cross-functional teams through change initiatives effectively. Exceptional communication skills to articulate technical information clearly to diverse audiences; ability to influence stakeholders at all levels. Relevant certifications such as RAC (Regulatory Affairs Certification) or CQE (Certified Quality Engineer) are preferred. Bachelor's degree in Engineering, Quality Management, Life Sciences or a related field; advanced degrees are a plus. Join us as we champion excellence in product safety and compliance! This role offers an exciting opportunity to shape our quality landscape while working with innovative teams committed to making a difference worldwide.