Senior Regulatory Affairs Specialist

📋 Description

• Provide regulatory guidance to product teams and approve design controls.
• Define US/Canada regulatory pathways; assess design/process impact.
• Lead regulatory docs and submissions (FDA 510(k), Health Canada).
• Coordinate with experts; respond to regulators to facilitate approvals.
• Provide risk-based regulatory input; ensure cross-functional alignment.
• Collaborate with international teams on global regulatory submissions.

🎯 Requirements

• 8+ years regulatory affairs in medical devices.
• Deep knowledge of US FDA, Health Canada, EU MDR.
• Design controls, risk management, V&V, labeling experience.
• BS or higher in Biomedical/Electrical/Mechanical Eng or Pharmacy.
• Fast-paced, multi-project delivery; strong written/verbal comms.
• RAC certification is preferred.

🎁 Benefits

• Vaccination proof may be required.
• Intuitive is an Equal Opportunity Employer.
• Export controls may apply to some roles.
• Export license or TCP may be required before start.
• Fair chance hiring applies.
• Role may be filled at a different level.