Director Quality Assurance Regulatory Affairs

Director of Quality & Regulatory Affairs About the Opportunity

We are seeking an experienced Director of Quality & Regulatory Affairs to lead quality and regulatory activities for an innovative medical device company focused on improving patient outcomes. This is a high-impact leadership role for someone who thrives in a hands-on, fast-paced environment and enjoys building and maintaining compliant quality systems while partnering across the organization.

The ideal candidate has a strong background in medical devices, with expertise in Quality Management Systems (QMS), FDA regulations, and Regulatory Affairs, along with experience supporting products that operate within the Durable Medical Equipment (DME) and Medicare reimbursement landscape.

• Lead and maintain the company's Quality Management System (QMS) in compliance with FDA regulations and ISO 13485
• Oversee regulatory strategy, submissions, product registrations, and ongoing compliance activies
• Ensure compliance with applicable FDA, ISO, and other regulatory requirements
• Manage internal and external audits, inspections, CAPA, complaints, nonconformances, and risk management activities
• Partner with engineering, manufacturing, operations, and executive leadership to support product development and commercialisation
• Maintain quality documentation, procedures, and design history files
• Support supplier quality management and manufacturing quality initiativies
• Monitor regulatory changes and implement necessary updates across the organization
• Serve as the company's quality and regulatory subject matter expert
• Required Qualifications
• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline
• 7+ years of Quality and/or Regulatory Affairs experience within the medical device industry
• Strong knowledge of FDA medical device regulations (21 CFR Part 820) and ISO 13485
• Experience leading Quality Management Systems in a medical device environment
• Experience managing FDA inspections, audits, CAPA, risk management, and quality compliance programs
• Experience supporting Class II and/or wearable medical devices
• Excellent communication, leadership, and cross-functional collaboration skills
• Highly Preferred Qualifications
• Experience with Durable Medical Equipment (DME) products
• Knowledge of Medicare Part B reimbursement, HCPCS coding, and reimbursement-driven medical device businesses
• Experience with prescribed, patient-worn medical devices
• Experience working in a startup or small, growing medical device company
• Experience in site-level or manufacturing quality leadership rather than exclusively corporate quality functions
• Ability to work independently and wear multiple hats in a lean organization

This role is ideal for someone who enjoys being close to the product and the business—not just overseeing processes from a distance. You'll be part of a collaborative leadership team where your expertise will directly influence product quality, regulatory success, and patient outcomes. If you're passionate about building compliant systems, solving complex regulatory challenges, and making a meaningful impact in medical technology, we'd love to hear from you.

This is a hybrid position based in Pennsylvania. Candidates should be able to commute to the office at least two days per week

• Annual performance-based bonus
• 401(k)
  Three weeks of paid vacation
• Opportunity to join a growing medical device company making a meaningful impact on patient care.