Quality Assurance & Regulatory Strategy Director

Health Staffing Group; Minnesota; On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical benefits

Retirement plan

Paid time off

Professional development

Leadership growth opportunities

Job summary

Health Staffing Group seeks a Director of Quality Assurance & Regulatory Affairs to lead the QMS, regulatory affairs, and compliance programs. You will ensure products and processes meet FDA and ISO 13485 standards while driving continuous improvement.

You will collaborate with executive leadership and cross-functional teams to manage regulatory submissions, audits, supplier quality, and quality metrics, shaping the organization's quality strategy and performance.

Qualifications

• Bachelor's degree in Engineering, Quality, Regulatory Affairs, Life Sciences, or a related field.
• 7–10 years of progressive leadership experience in QA and regulatory affairs within medical devices.
• Strong knowledge of FDA regulations, ISO 13485, and device quality system requirements.
• Experience with FDA inspections, ISO certification audits, and regulatory programs.
• Experience with 510(k) submissions and regulatory processes.
• Proven leadership, communication, and organizational skills.
• Experience leading cross-functional teams and driving organizational change.

Responsibilities

• Lead and maintain the organization's QMS to ensure regulatory compliance.
• Oversee regulatory affairs activities, including submissions and agency communications.
• Ensure compliance with FDA regulations, ISO 13485, and related requirements.
• Direct audits and ensure timely resolution of findings.
• Manage document and change control processes for compliance.
• Lead CAPA program with investigation, actions, and verification.
• Facilitate Management Review meetings and present metrics.
• Oversee supplier qualification, performance monitoring, and audits.
• Manage customer complaint investigations and regulatory reporting.
• Develop and communicate quality performance indicators and objectives.
• Lead and develop the QA and Regulatory Affairs team.
• Partner with Operations, Engineering, Manufacturing, and Supply Chain to improve quality and risk management.
• Promote a culture of quality, compliance, and continuous improvement.

Skills

Leadership

Regulatory compliance

Quality management

FDA regulations

Cross-functional leadership

Analytical thinking

Education

Bachelor's degree

Master's degree

Job description

Health Staffing Group seeks a Director of Quality Assurance & Regulatory Affairs to lead the QMS, regulatory affairs, and compliance programs. You will ensure products and processes meet FDA and ISO 13485 standards while driving continuous improvement.

You will collaborate with executive leadership and cross-functional teams to manage regulatory submissions, audits, supplier quality, and quality metrics, shaping the organization's quality strategy and performance.