Senior FDA 510 K Regulatory Consultant (510k / MDR) – Verified Partner Network
About Cruxi: (cruxi.ai)
Cruxi has rapidly become the #1 destination globally for 510(k) intelligence, ranking on the first page of Google and becoming the "Go-To" resource for medical device manufacturers worldwide. Our platform combines AI-driven eSTAR drafting with human expertise.
The Opportunity:
We are opening our Verified Partner Network to a select group of independent consultants.
This is not a traditional full-time job. It is an application to receive priority lead routing from the industry's highest-traffic regulatory ecosystem.
How You Get Clients (The Dual-Engine Model):
By verifying your credentials with Cruxi, you gain visibility in two exclusive areas:
• The In-App Workflow (The "Silver Platter" Handoff):
• The Process: Cruxi users utilize our AI to handle the heavy lifting: Device Intake → Classification → Predicate Analysis → eSTAR Drafting → RTA Packaging.
• The Handoff: Once the technical documentation is prepared, users request a Human Expert for the final "Redline Review" and to manage FDA communications.
• Your Advantage: You don't start from scratch. You receive a client with a 90% complete eSTAR draft, allowing you to focus on high-value strategy and final submission management.
2.The #1 Ranked Public Directory (High Volume):
• Leverage our SEO dominance. Your profile will be featured in our public directory, capturing the massive volume of organic search traffic we drive daily.
Partner Benefits:
• Zero Commission (Beta): Keep 100% of your billable rate on initial matched projects.
• Partner Technology Stack: All Verified Partners receive a Lifetime 50% Discount on Cruxi’s professional tools, including our AI 510(k) Modification Assessment Engine—giving you a competitive edge over manual consultants.
Who We Are Vetting:
• Senior Independent Consultants or Agency Founders.
• Proven history of 510(k) clearances or Technical File approvals.
• Capacity to handle final reviews and FDA correspondence for 1-3 new clients in Q1 2025.
Application & Consent:
• Click Easy Apply to submit your CV for verification.
• Note: By applying, you consent to having a professional profile generated in the Cruxi Partner Ecosystem (Public & Private) upon verification.
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