Head of Regulatory

📋 Description

• Lead the regulatory function for a Healthtech AI company within Engineering.
• Own global regulatory strategy and ensure alignment with business goals.
• Coordinate regulatory filings with FDA, Health Canada, EU Notified Bodies, UK MHRA, and other
• Embed regulatory requirements across product lifecycle with cross-functional teams.
• Build and manage a global regulatory team as the company scales.

🎯 Requirements

• 7+ years in regulatory affairs for medical devices, including SaMD under FDA.
• Experience with FDA 510(k), De Novo, CE Marking, MDEL, UK MHRA, TGA.
• Deep knowledge of FDA, Health Canada, EU MDR/IVDR, UK MDR, and Australian TGA frameworks.
• Experience interacting with agencies/notified bodies and leading inspections.
• ISO 13485, ISO 14971, IEC 62304; HIPAA/GDPR familiarity a plus.
• Bachelor degree; advanced degree or RAC preferred.

🎁 Benefits

• Hybrid workplace with flexible in-person and remote options.
• Competitive compensation and equity.
• 401k with matching; comprehensive medical, dental, and vision coverage.
• Paid parental leave; HSA option; PTO and holidays.
• Learning and development stipend; supportive hybrid culture.