Director, Global Regulatory Affairs & Intelligence

📋 Description

• Own end-to-end regulatory strategy from concept to commercialization.
• Lead regulatory submissions (FDA 510(k)/De Novo, CE Mark, Health Canada, PMDA).
• Regulatory lead, managing pre-submissions, deficiencies, inspections.
• Partner with R&D, Quality, Clinical, Product to embed regulatory requirements.
• Establish regulatory intelligence to monitor EU MDR, AI Act, FDA SaMD.
• Build and mentor a high-performing regulatory team and optimize submission workflows.

🎯 Requirements

• Bachelor's in a STEM field; advanced degree preferred.
• 10+ years in regulatory affairs for Class II devices and SaMD; FDA approvals.
• Deep expertise in FDA 510(k)/De Novo, EU MDR, ISO 13485, MDSAP.
• Proven track record with regulatory authorities (pre-submission, inspections).
• Proficiency with regulatory software (Veeva Vault/MasterControl) and submission platforms (eSTAR/EUDAMED).
• Strong communication and leadership; able to influence cross-functional teams.

🎁 Benefits

• The opportunity to work on products that impact the health of millions of people.
• Generous paid-time off.
• Stock incentive plans.
• Medical/Dental/Vision, Disability + Life Insurance.
• One Medical membership.
• Parental Leave.