Remote Medical Device QMS Specialist
Budget: $15 – $25 USD
I’m looking for a seasoned compliance professional who can step straight into our ISO 13485-regulated environment and update our Quality Management System processes and documents. The immediate focus is tightening up our document maintenance: every SOP, work instruction, form, and record must be current, traceable, and filed so that an FDA inspector or EU auditor can find what they need in seconds (although we are a start-up and don't yet have production or device sales). We have a legacy QMS for a different product and now need to develop a Design History File that puts all of the previous design work into a compliant document (since no effort was made during the previous two years to maintain the QMS during R&D on the new product). We need help to adapt and revise the original document templates to match the new product and get all the previous development work documented and brought up to date.
Alongside that documentation work, I’ll rely on you to keep a watchful eye on three key process streams:
• Manufacturing processes (which will involve monitoring third-party contract manufacturing)
• Quality control processes (establishing test procedures for the factory to follow and document)
• Risk management processes
When deviations or gaps appear, you’ll guide the team on corrective and preventive actions, then close the loop in the QMS.
Regulatory submissions are next on the agenda. You should already be comfortable assembling and polishing both FDA and EU MDR filings—building the technical file, cross-linking evidence, and making sure any claim is backed by verifiable data.
Key tools and standards in daily use include ISO 13485, 21 CFR 820, ISO 14971, and the EU MDR annexes. Experience with electronic QMS platforms (e.g., Greenlight Guru, Ketryx, or similar) will help you hit the ground running.
Deliverables I expect:
1. A fully updated, audit-ready document set stored in our eQMS.
2. Weekly status reports outlining open actions across manufacturing, QC, and risk management.
3. Drafts of upcoming FDA and EU MDR submissions with tracking matrices showing outstanding data needs.
4. A short final summary confirming that all non-conformities and CAPAs raised during your tenure have been closed or routed for follow-up.
If you can demonstrate recent success keeping medical device firms compliant under both jurisdictions, I’d love to see how you can do the same for us.
Our product (as planned and ready for launch by the end of the year) may be seen at https://biotx.ltd.
Alongside that documentation work, I’ll rely on you to keep a watchful eye on three key process streams:
• Manufacturing processes (which will involve monitoring third-party contract manufacturing)
• Quality control processes (establishing test procedures for the factory to follow and document)
• Risk management processes
When deviations or gaps appear, you’ll guide the team on corrective and preventive actions, then close the loop in the QMS.
Regulatory submissions are next on the agenda. You should already be comfortable assembling and polishing both FDA and EU MDR filings—building the technical file, cross-linking evidence, and making sure any claim is backed by verifiable data.
Key tools and standards in daily use include ISO 13485, 21 CFR 820, ISO 14971, and the EU MDR annexes. Experience with electronic QMS platforms (e.g., Greenlight Guru, Ketryx, or similar) will help you hit the ground running.
Deliverables I expect:
1. A fully updated, audit-ready document set stored in our eQMS.
2. Weekly status reports outlining open actions across manufacturing, QC, and risk management.
3. Drafts of upcoming FDA and EU MDR submissions with tracking matrices showing outstanding data needs.
4. A short final summary confirming that all non-conformities and CAPAs raised during your tenure have been closed or routed for follow-up.
If you can demonstrate recent success keeping medical device firms compliant under both jurisdictions, I’d love to see how you can do the same for us.
Our product (as planned and ready for launch by the end of the year) may be seen at https://biotx.ltd.