Fractional QA/RA Advisor – Class ...

About the role

We are an established small medical device manufacturer seeking a fractional, remote Quality Assurance and Regulatory Affairs (QA/RA) Advisor. This long-term retainer role requires 15–20 hours per month to maintain our existing Quality Management System (QMS), ensure ongoing compliance for our Class II devices, and support our global market access. We currently market and sell our products in the US and some countries in the Middle East, and are expanding our regulatory footprint further into the Middle East, as well as into Central and South America.

Responsibilities

• QMS Maintenance: Oversee and maintain our established QMS to ensure ongoing compliance with FDA 21 CFR Part 820, ISO 13485:2016, and international standards.
  • Document Control / Change Orders
  • Product Releases
  • Handling Complaints
  • Approve Design Control Documents
  • Nonconformances
• Regulatory Maintenance: Manage active device listings, establishment registrations, and post-market compliance for the US (FDA) and Middle Eastern markets (e.g., Saudi FDA, UAE MoH).
  • FDA Inspections
  • 510(k) documents (no 510k rationales/submission documents)
  • Act as Management Representative
• Middle East – Ongoing Expansion: Guide registration strategies, dossier preparation, and regulatory submissions, ensuring compliance and readiness to sell into all target countries.
• Latin American Expansion: Guide registration strategies, dossier preparation, and submissions for Central and South American regulatory bodies.
• Quality Operations Support: Provide remote guidance on internal audits, CAPAs, complaints, change controls, and management reviews.
• Knowledge Transfer: Participate in a paid transition/handover period with our outgoing consultant.

Requirements

• Experience: 7+ years of QA/RA experience explicitly working with Class II medical devices.
• Market Expertise: Proven track record maintaining active regulatory approvals in the US, alongside direct experience navigating Middle Eastern, Central and South American medical device regulations.
• MDSAP Knowledge: Experience with the Medical Device Single Audit Program (MDSAP) is highly preferred.
• Setup: Fully equipped for remote collaboration with excellent independent project management skills.

Schedule

15–20 hours per month.