Director of Quality Assurance & Regulatory Affairs

Job Title: Director of Quality Assurance & Regulatory Affairs



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.

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.

Thank you,

Kay Raguindin
Division Manager
Health Staffing Group
View phone number on us.fitly.work (Direct Line)
Mon Thurs 9am-6pm EST
Fridays 9am-1pm EST