Careers at Cruxi
Join our team. We're seeking Regulatory Affairs Experts with exceptional knowledge of FDA regulations AND artificial intelligence.
Regulatory Affairs Consultant - FDA & AI Specialist (Consultant Network)
About This Role
Join Cruxi's elite consultant network. Work with medical device companies to navigate complex 510(k) submissions using our cutting-edge AI-powered regulatory platform. This is not a generic marketplace—we're curating a small group of experts who can step into complex projects quickly and confidently.
You're a good fit if:
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You've led or contributed to multiple 510(k) submissions (cleared or in review)
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You're comfortable working directly with MedTech teams (not just writing reports)
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You can review AI-drafted content, spot gaps fast, and guide teams to a submission-ready package
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You respond reliably and treat this as part of your professional practice
This is probably not for you if:
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You're just "curious" about FDA work and haven't done it hands-on
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You prefer low-commitment, one-off calls rather than real project ownership
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You're looking for a general consulting directory, not FDA-specific work
Ready to Apply?
Join our elite consultant network and help shape the future of medical device regulatory submissions.
Apply to Consultant Network arrow_forwardApplication takes 5-10 minutes · Review process takes up to 2 weeks
Regulatory Affairs Expert - FDA & AI Specialist (Internal Position)
About This Role
Cruxi is revolutionizing medical device regulatory submissions through AI-powered automation. We're building the future of regulatory affairs, and we need experts who understand both the complexity of FDA regulations and the power of artificial intelligence.
As a Regulatory Affairs Expert in our internal team, you'll work directly with Cruxi to help medical device companies navigate complex 510(k) submissions using our cutting-edge AI platform. You'll review AI-generated regulatory content, guide companies through FDA requirements, and ensure all submissions meet the highest quality standards.
This is an internal position at Cruxi. You'll be working at the intersection of regulatory expertise and AI technology—helping shape the future of medical device submissions.
Required Qualifications
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5+ years of hands-on FDA regulatory experience with direct involvement in 510(k) submissions (cleared or in review)
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Deep understanding of FDA regulations, guidance documents, regulatory pathways, and quality systems (21 CFR 820, ISO 13485)
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Strong knowledge of artificial intelligence and machine learning—you understand how AI works, its capabilities, and its limitations in regulatory contexts
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Experience reviewing and validating AI-generated content—you can spot gaps, identify inaccuracies, and guide improvements in AI outputs
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Proven track record of successful 510(k) submissions with FDA clearance
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Excellent communication skills—ability to work directly with medical device companies, explain complex regulatory concepts, and guide teams
Preferred Qualifications
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RAC (Regulatory Affairs Certification) or equivalent professional certification
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Advanced degree (MS, PhD, or equivalent) in Engineering, Life Sciences, or related field
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Experience with eSTAR submissions and FDA's electronic submission requirements
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Knowledge of AI/ML applications in healthcare, medical devices, or regulatory technology
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Experience with cybersecurity requirements for medical devices (SAMD guidance)
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Familiarity with risk management standards (ISO 14971) and design controls
⚠️ Important: This Role Requires BOTH FDA and AI Expertise
This is not a role for traditional regulatory consultants who are unfamiliar with AI. You must have genuine understanding of both FDA regulations AND artificial intelligence. We're looking for experts who can:
- Understand how AI models work and their limitations in regulatory contexts
- Review AI-generated regulatory content with a critical eye
- Guide improvements to AI outputs based on FDA requirements
- Explain AI capabilities and limitations to medical device companies
- Work effectively with AI-powered tools to streamline regulatory processes
If you don't have experience with both FDA regulations AND AI/ML technologies, this role is not a good fit.
What You'll Do
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Review and validate AI-generated regulatory content for 510(k) submissions, ensuring accuracy and compliance with FDA requirements
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Guide medical device companies through complex regulatory processes, providing expert consultation on FDA requirements and regulatory strategies
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Work with cutting-edge AI tools to streamline regulatory submissions while maintaining the highest quality standards
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Identify gaps in AI-generated content and provide guidance for improvements based on FDA regulations and best practices
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Work directly with Cruxi's internal team to improve our AI platform and regulatory processes
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Ensure all submissions meet FDA quality standards and are ready for successful clearance
Benefits & Perks
100% Remote Work
Work from anywhere in the US
Competitive Salary
Competitive compensation package
Health Insurance
Comprehensive health benefits
Cutting-Edge Technology
Work with the most advanced AI-powered regulatory platform
Professional Development
Stay at the forefront of AI and regulatory technology
Team Collaboration
Work with a talented team of experts
Ready to Apply?
If you have the exceptional combination of FDA regulatory expertise AND AI knowledge, we want to hear from you. Send your CV to:
mail cruxi@cruxi.aiPlease include your CV and a brief note about your experience with FDA regulations and AI/ML technologies
Call for Partnership: FDA 510(k) Expert Review & Finalization Providers
About This Partnership
Cruxi is inviting experienced FDA 510(k) consultants and regulatory service providers to partner with us as expert human review and finalization providers for our AI-assisted 510(k) workflow.
The current workflow guides users through device intake, classification, predicate analysis, regulatory assessment, eSTAR section mapping, AI-assisted draft generation, evidence checklist preparation, and final expert review.
At the moment, the final expert review step directs users to a provider directory. We are now looking to replace that final step with one or two selected expert providers who can offer a clear, end-to-end expert review and finalization service with automatically calculated pricing inside Cruxi.
View the current demo workflow here: 510(k) workflow demo
Partnership Opportunity
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Selected partners will be integrated directly into the Cruxi 510(k) workflow as expert review and finalization providers.
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Instead of sending users to a general directory, Cruxi intends to show a clear expert review option at the final step.
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The user experience would include provider name, service description, what is included, what is not included, turnaround time, automatically calculated price, provider approval or counteroffer option, and payment through Cruxi.
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This gives users a complete path from AI-assisted preparation to expert human finalization.
What Expert Partners Would Provide
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Review of Cruxi-generated 510(k) draft packages and final submission-readiness quality review.
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Validation of classification, regulation number, product code, predicate selection, substantial equivalence rationale, and applicable eSTAR sections.
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Gap analysis against FDA expectations across labeling, indications for use, device description, performance testing, software, cybersecurity, biocompatibility, sterilization, electrical safety, EMC, human factors, clinical data, and other applicable evidence areas.
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Optional advisory calls, FDA submission support, FDA interactive review response support, and Q-submission support where offered by the provider.
Pricing Requirement
A key requirement is structured pricing. Cruxi needs to show the user an estimated price immediately inside the workflow, so we are looking for providers who can give us a clear pricing formula rather than relying only on case-by-case quotes.
The automatically calculated price would be shown to the user upfront based on the provider's pricing formula and the user's intake information. The provider would still have the option to approve the calculated price or submit a counteroffer if the case requires a different scope, complexity adjustment, or custom pricing.
Please price this as expert review and finalization of a Cruxi-prepared draft, not as full 510(k) preparation from scratch.
Interested providers should submit pricing details such as base price, pricing tiers for standard/moderate/complex devices, fixed add-on prices, turnaround times, minimums, and any scope limits before a custom quote is required.
Service Scope Details Required
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Please clearly define what your service includes, such as full draft review, classification and product code review, predicate review, applicable eSTAR sections, gap report, written comments, direct edits, revision rounds, client calls, final submission-readiness check, packaging support, submission support, and interactive review support.
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Please also specify what is excluded, such as creating missing test reports, conducting laboratory testing, writing full clinical study reports, designing new studies, preparing new cybersecurity or biocompatibility testing, full Q-submission strategy, post-submission FDA interaction, extra revision rounds, major scope changes, or new intended use changes.
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This is important so Cruxi can present the service transparently to users before payment.
Stripe Connect & Platform Fee
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Users would pay directly through the Cruxi platform, with provider payouts handled through the provider's connected Stripe account.
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Interested providers should confirm whether they can receive payments through Stripe Connect or are willing to set up a connected Stripe account for Cruxi-referred projects.
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Cruxi charges a 10% platform transaction fee on completed expert review transactions processed through the platform.
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Providers may either submit pricing that already includes the Cruxi platform fee or submit their required net amount so Cruxi can calculate the user-facing price accordingly.
Why Partner With Cruxi
Better Prepared Clients
Receive companies who already completed structured intake and AI-assisted draft preparation.
Faster Review Cycles
Spend less time organizing basic submission structure and more time on high-value expert review.
Clearer Scope & Pricing
Use structured pricing with the ability to approve or counteroffer before accepting the project.
Workflow Placement
Be placed directly at the final step of an AI-powered 510(k) workflow instead of relying on passive directory visibility alone.
Built-in Payment Flow
Payment routing happens through Cruxi, with provider payouts handled through Stripe Connect.
High-Intent 510(k) Demand
Access companies actively preparing 510(k) submissions and looking for expert finalization support.
Who We Are Looking For
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Consultants and firms with experience in FDA 510(k) submissions, eSTAR preparation and review, predicate analysis, and substantial equivalence.
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Providers comfortable supporting software as a medical device, cybersecurity documentation, human factors, biocompatibility and safety documentation, electrical safety and EMC, sterile or patient-contacting devices, AI/ML-enabled devices, and FDA interactive review responses.
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Ideally one or two providers who can cover the full expert review and finalization scope rather than many fragmented providers.
What To Submit
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Company name, website, main contact, overview of FDA 510(k) experience, specialties, and examples of project types handled.
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Your proposed pricing formula or pricing tiers, fixed add-on pricing, turnaround times, scope inclusions, exclusions, scope limits, and whether pricing is user-facing or your required net amount before Cruxi's 10% platform fee.
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Whether you support eSTAR review and finalization, full expert review scope, FDA submission support, interactive review responses, Stripe Connect payouts, and the approve-or-counteroffer workflow.
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Your availability to accept new Cruxi-referred review projects.
Important Note
Cruxi is a software platform and AI-powered workflow provider. Cruxi does not provide regulatory, legal, medical, or professional advice. Expert review and professional judgment are provided by independent qualified consultants or firms within the Cruxi provider network.
Interested?
Email cruxi@cruxi.ai with the subject line 510(k) Expert Review Partnership.
mail Email Cruxi