Director of QA & RA

This role leads all Regulatory Affairs and Quality Assurance activities, ensuring global compliance while supporting rapid growth and innovation. You'll partner closely with senior leadership to guide regulatory strategy across the full product lifecycle.

Client Details

This is a fast‑growing, innovation‑driven medical device company focused on delivering high‑impact technologies that improve patient outcomes. The organization values quality, collaboration, and continuous improvement as it expands its global footprint.

Description

• Lead, manage, and develop the Regulatory Affairs and Quality Assurance functions across the organization
• Own and continuously improve the Quality Management System in compliance with FDA QSR, ISO 13485, and global regulatory standards
• Drive internal audits and manage external audits from regulatory agencies, notified bodies, and customers
• Oversee global regulatory submissions including FDA 510(k), EU MDR technical documentation, and international approvals
• Serve as the primary liaison with regulatory authorities and external partners
• Provide strategic regulatory and quality input for new product development, design changes, and lifecycle management
• Lead core quality processes including CAPA, risk management, document control, training, and quality metrics
• Advise executive leadership on regulatory strategy, compliance status, and risk manageme

Profile

• Bachelor's degree in a scientific or engineering discipline; advanced degree preferred
• 8+ years of experience in Medical Device Regulatory Affairs and Quality Assurance
• Strong hands‑on knowledge of FDA QSR, ISO 13485, and EU MDR
• Proven experience preparing regulatory submissions and supporting inspections and audits
• Demonstrated leadership experience in a fast‑paced, cross‑functional medical device environment
• Excellent communication skills with the ability to influence senior stakeholders

Job Offer

• Make a direct impact on innovative medical technologies that improve patient lives
• Take on a true leadership role with ownership over regulatory and quality strategy
• Work cross‑functionally with experienced teams across R&D, Manufacturing, and Operations
• Join a growing organization with global expansion opportunities
• Competitive compensation, strong benefits, and long‑term career growth

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.