Job Description
📋 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.
