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October 22, 2026
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Gainesville, Florida
October 14, 2026
Director of Quality Assurance & Regulatory Affairs
Location
Saint Paul, Minnesota
Workplace Type
On-site
Salary
$150,000 - $180,000
Job Description
Job Title: Director of Quality Assurance & Regulatory Affairs
Reports To: President
Reports To: President
About the Role:
This role is responsible for providing strategic leadership and oversight of the organization's Quality Management System (QMS), regulatory affairs, compliance programs, and quality assurance initiatives. The Director of Quality Assurance & Regulatory Affairs ensures products, processes, and quality systems comply with applicable regulatory requirements, industry standards, and customer expectations while fostering a culture of continuous improvement.
Working closely with executive leadership and cross-functional teams, this position oversees regulatory submissions, quality system performance, supplier quality, customer complaint management, and audit readiness. The ideal candidate is a collaborative leader with extensive experience in medical device quality systems, regulatory compliance, and operational excellence.
Key Responsibilities:
• Lead and maintain the organization's Quality Management System (QMS) to ensure compliance with applicable regulations and quality standards.
• Oversee regulatory affairs activities, including regulatory submissions, product registrations, and agency communications.
• Ensure compliance with FDA regulations, ISO 13485, and other applicable quality and regulatory requirements.
• Direct internal, customer, supplier, and regulatory audits while ensuring timely resolution of findings.
• Manage document control and change control processes to maintain compliance and operational efficiency.
• Lead the Corrective and Preventive Action (CAPA) program, ensuring effective investigation, implementation, and verification of corrective actions.
• Facilitate Management Review meetings and present quality system performance metrics to executive leadership.
• Oversee supplier qualification, supplier performance monitoring, and supplier quality audits.
• Manage customer complaint investigations, trending, and regulatory reporting requirements.
• Develop, monitor, and communicate key quality performance indicators and organizational quality objectives.
• Lead, mentor, and develop the Quality Assurance and Regulatory Affairs team.
• Partner with Operations, Engineering, Manufacturing, and Supply Chain to drive quality improvements, risk reduction, and continuous process optimization.
• Promote a culture of quality, compliance, and continuous improvement throughout the organization.
Qualifications:
Required:
• Bachelor's degree in Engineering, Quality, Regulatory Affairs, Life Sciences, or a related field.
• Minimum of 7–10 years of progressive leadership experience in Quality Assurance and Regulatory Affairs within the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, and medical device quality system requirements.
• Experience managing FDA inspections, ISO certification audits, and regulatory compliance programs.
• Experience with 510(k) submissions and medical device regulatory processes.
• Proven leadership, communication, and organizational skills.
• Strong analytical and problem-solving abilities.
• Experience leading cross-functional teams and driving organizational change.
Preferred:
• Master's degree in Engineering, Business Administration, Regulatory Affairs, or a related discipline.
• Professional certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), RAC, or equivalent.
• Experience with supplier quality management and risk management methodologies.
• Knowledge of global regulatory requirements and international quality standards.
• Experience implementing continuous improvement initiatives within regulated manufacturing environments.
• Master's degree in Engineering, Business Administration, Regulatory Affairs, or a related discipline.
• Professional certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), RAC, or equivalent.
• Experience with supplier quality management and risk management methodologies.
• Knowledge of global regulatory requirements and international quality standards.
• Experience implementing continuous improvement initiatives within regulated manufacturing environments.
What We Offer:
• Competitive executive compensation package.
• Comprehensive medical, dental, and vision benefits.
• Employer-sponsored retirement savings plan.
• Paid time off and company holidays.
• Professional development and leadership growth opportunities.
• Collaborative leadership team focused on innovation, quality, and operational excellence.
• Opportunity to shape organizational quality strategy and drive continuous improvement across the business.
• Competitive executive compensation package.
• Comprehensive medical, dental, and vision benefits.
• Employer-sponsored retirement savings plan.
• Paid time off and company holidays.
• Professional development and leadership growth opportunities.
• Collaborative leadership team focused on innovation, quality, and operational excellence.
• Opportunity to shape organizational quality strategy and drive continuous improvement across the business.
#HSG123
Thank you,
Kay Raguindin
Division Manager
Health Staffing Group
(954) 998 – 7664 (Direct Line)
Mon – Thurs 9am-6pm EST
Fridays 9am-1pm EST
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