💼 About This Role

You'll lead global regulatory strategy for Dozee's medical devices and SaMD products. You'll manage FDA and EU MDR submissions, ensure compliance with international standards, and mentor a growing team. This role offers the chance to shape the regulatory landscape of innovative healthcare technologies.

🎯 What You'll Do

• Evaluate regulations and develop global regulatory strategies.
• Author and manage FDA submissions (510(k), Q-Subs).
• Prepare EU Technical Documentation and support CE Marking.
• Mentor junior regulatory team members.
• Assess product changes for regulatory impact.

📋 Requirements

• 6+ years of Regulatory Affairs experience in medical devices/SaMD.
• Bachelor’s degree required; MBA a plus.
• Strong experience with US FDA Class I and II medical devices.
• Proven end-to-end regulatory submissions and approvals.

✨ Nice to Have

• ISO 13485 Auditor Certification (external auditor).
• Familiarity with AI Acts and software-driven regulations.

🎁 Benefits & Perks

• 🏥 Health Insurance
• 💰 Competitive Compensation
• 📈 Career Growth