💼 About This Role

You'll lead FDA premarket submissions for a digital health platform that blends compounding and medical technologies. Your core impact is bridging legal requirements with regulatory execution across the entire ecosystem. This high-impact role lets you build the 'Technical Playbook' for medical product operations.

🎯 What You'll Do

• Own end-to-end lifecycle of FDA premarket applications, focusing on 510(k) submissions.
• Operationalize compliance across FDA, DEA, CMS/CLIA, and FTC jurisdictions.
• Serve as lead regulatory contact for agency audits and inspections.
• Build and scale the 'Technical Playbook' for medical product operations.

📋 Requirements

• 12+ years in Regulatory Affairs with emphasis on medical devices and IVDs.
• Proven track record of authoring multiple successful 510(k) clearances for IVDs.
• Deep experience with FDA, DEA, CMS/CLIA, and FTC regulations.
• Advanced degree (Masters in Regulatory Affairs, PhD, JD) or equivalent experience.

✨ Nice to Have

• Experience with pharmacy compounding.
• International regulatory experience.

🎁 Benefits & Perks

• 💰 Competitive salary & equity compensation
• 🏖️ Unlimited PTO and quarterly mental health days
• 🏥 Comprehensive health benefits including medical, dental, vision, and parental leave
• 📈 Employee Stock Purchase Program (ESPP)
• 🏦 401k with employer matching

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter screen· 30 min
2. 2Hiring manager interview· 45 min
3. 3Technical/behavioral interview· 60 min
4. 4Offer· N/A