Looking for an experienced Regulatory & Quality Assurance Supervisor to help us maintain compliance and drive excellence in our QMS. This role is perfect for someone who thrives in dynamic environments and wants to make a direct impact on patient safety and product quality.

What you’ll do:

• Serve as a key point of contact during FDA, ISO, and international audits
• Familiarity with 510(k) submissions, MDRs/Vigilance reporting, and regulatory filings
• Manage and improve the Quality Management System (QMS), including internal audits, change control, and risk management
• Collaborate across teams to ensure compliance and timely submissions
• Provide leadership, mentoring, and oversight to one Associate level direct report

What we’re looking for:

• 5+ years of Regulatory Affairs and Quality Assurance experience in medical devices (preferably Spinal or Orthopedic experience)
• Strong knowledge of FDA and ISO regulations
• Experience facilitating audits and managing regulatory submissions
• Excellent leadership, organizational, and problem-solving skills
• Regulatory Affairs Certification (RAC) preferred