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)

location_on Remote (US)
schedule Flexible Hours
work Contractor / Part-time / Full-time
attach_money Competitive Compensation

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_forward

Application takes 5-10 minutes · Review process takes up to 2 weeks

Regulatory Affairs Expert - FDA & AI Specialist (Internal Position)

location_on Remote (US)
schedule Full-time / Part-time
work Internal Position
attach_money Competitive Salary

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

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100% Remote Work

Work from anywhere in the US

payments

Competitive Salary

Competitive compensation package

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Health Insurance

Comprehensive health benefits

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Cutting-Edge Technology

Work with the most advanced AI-powered regulatory platform

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Professional Development

Stay at the forefront of AI and regulatory technology

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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.ai

Please include your CV and a brief note about your experience with FDA regulations and AI/ML technologies