Quality & Regulatory Manager

At the forefront of health tech innovation, CopilotIQ is transforming in-home care with the industry's first AI-driven platform that supports individuals through every stage of their health journey-from pre-surgical optimization to acute, post-acute and chronic care. We are helping people live healthier, longer lives by bringing personalized, proactive care directly into their homes. If you're passionate about driving real change in healthcare, join the Team!

We are looking for a Quality & Regulatory Manager to own our Quality Management System and ensure we meet regulatory and compliance requirements. You’ll be the point person for 510(k) submissions, CAPA, audits, and day-to-day compliance - while also helping us build scalable processes as we grow.

This is a hands-on role: we need someone who is comfortable rolling up their sleeves, moving fast, and balancing rigor with startup practicality.

• Lead and manage regulatory submissions, including 510(k) filings, amendments, and ongoing maintenance.
• Maintain and improve our QMS (ISO 13485, 21 CFR Part 820) in a lightweight, startup-friendly way.
• Drive CAPA investigations, root cause analysis, and effectiveness checks.
• Own document control, risk management, complaint handling, and post-market surveillance.
• Support internal/external audits and be the primary contact for FDA or notified bodies.
• Partner with engineering, product, and clinical teams to integrate compliance early in the product lifecycle.
• Keep leadership updated on regulatory changes and practical implications.Train teammates on compliance best practices (without slowing them down).

• Bachelor’s degree required; Master’s degree preferred in Regulatory Affairs, Clinical Research Management, or a related field.
• 5–7 years of experience in regulatory/quality roles in medical devices, SaMD, or digital health.
• Hands-on experience with FDA 510(k) submissions.
• Solid working knowledge of QMS standards (ISO 13485, 21 CFR Part 11/820, ISO 14971).
• Comfortable being the sole regulatory/quality owner in a small company.
• Excellent communicator who can translate “regulatory language” into startup action.
• Organized, detail-oriented, but pragmatic - you know when “good enough” is good enough.

Nice to Have

• RAC or ASQ certification.
• Experience with HIPAA/GDPR compliance.
• Prior startup or small-team experience.