💼 About This Role

You'll lead U.S. and international regulatory submissions for a kidney stone treatment device company, driving strategy from concept to commercialization. Your work will shape regulatory infrastructure and mentor junior team members in a high-visibility role.

🎯 What You'll Do

• Lead complex U.S. and international regulatory filings (510(k)s, Q-Subs, PMAs)
• Drive development of scalable regulatory infrastructure and processes
• Act as primary liaison with FDA and global regulatory bodies
• Provide regulatory input into product development and design reviews
• Mentor and develop junior Regulatory Affairs staff

📋 Requirements

• 12+ years experience in regulatory affairs in medical device industry
• Proven success leading multiple FDA submissions including 510(k)s and Q-Subs
• Expertise in biocompatibility, packaging, sterilization, and software (IEC 62304)
• Advanced understanding of U.S. and EU MDR regulations

✨ Nice to Have

• Experience with Class II or III electromechanical devices
• Knowledge of FDA QMSR transition activities
• Experience with eQMS systems

🎁 Benefits & Perks

• 🏖️ Unlimited PTO
• 🏥 Comprehensive health insurance
• 💰 401(k) matching
• 📈 Stock options
• 🏢 On-site gym

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter screen· 30 min
2. 2Hiring manager interview· 45 min
3. 3Technical interview· 60 min
4. 4Final executive interview· 45 min