Quality Assurance Regulatory Affairs Manager

Quality & Regulatory Affairs Manager — Durable Medical Equipment (DME) & Medicare Reimbursement 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 organisation.

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 operating 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
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• Oversee regulatory strategy, submissions, product registrations, and ongoing compliance activities.
• Ensure compliance with applicable FDA, ISO, and other regulatory requirements
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• 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 commercialization.
• Maintain quality documentation, procedures, and Design History Files (DHF).
• Support supplier quality management and manufacturing quality initiatives.
• Monitor regulatory changes and implement necessary updates across the organization.
• Serve as the company's quality and regulatory subject matter expert.

• Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related technical discipline.
• 7+ years of Quality and/or Regulatory Affairs experience within the medical device industry.
• Strong knowledge of:
• ISO 13485
• Experience leading Quality Management Systems in a medical device environment.
• Experience managing:
• FDA inspections
• Audits
• CAPA
• Quality compliance programs
• Experience supporting Class II and/or wearable medical devices
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• Excellent communication, leadership, and cross-functional collaboration skills.

• Experience with Durable Medical Equipment (DME) products.
• Knowledge of:
• HCPCS coding
• Experience with:
• Startup or small growing medical device companies
• Site-level or manufacturing quality leadership (not only corporate quality functions)
• Ability to work independently and manage multiple responsibilities 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 will be part of a collaborative leadership team where your expertise directly influences:

• Regulatory success
• Commercialization strategy

If you are passionate about building compliant systems, solving complex regulatory challenges, and making an impact in medical technology, we would like to hear from you.

• Annual performance-based bonus
• 401(k)

A Quality & Regulatory professional with experience in:

Medical Device QMS leadership

Class II and wearable devices

Patient-worn/prescribed medical devices