What are the responsibilities and job description for the Director of QA & RA position at Michael Page?
- Own and shape global regulatory and quality strategy
- Step into a senior leadership role with real influence
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.
Job 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
The Successful Applicant
- 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
- 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
Quote job ref: JN-042026-6988566
Salary : $160,000 - $190,000