Regulatory Affairs Specialist II

We're seeking a Regulatory Affairs Specialist II to provide regulatory support across a broad portfolio of Peripheral Intervention devices. The role will involve evaluation of post-market design changes, EU MDR compliance, and regulatory submissions for medical devices in the US and EU.

Requirements

• Support Regulatory Affairs activities related to peripheral vascular devices within the ICTx portfolio
• Represent Regulatory Affairs on core project teams
• Act as a liaison with regulatory agencies
• Prepare and submit regulatory documentation
• Review and approve product changes
• Participate in internal initiatives to improve quality systems
• Support department and divisional process improvements
• Participate in regulatory audits/inspections

Benefits

• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Retirement Plan
• Generous Paid Time Off
• Tuition Reimbursement