FDA Regulatory Consultant (Medical Device / 510k / MDR) – Verified Partner Network

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. Apply tot his job