Senior Principal Regulatory Affairs Specialist

The Senior Principal Regulatory Affairs Specialist will be responsible for regulatory strategies and associated daily activities, including managing regulatory projects, achieving regulatory deliverables, and ensuring compliance with FDA, EU, and other regulatory requirements.

Requirements

• 10+ years of experience in Medical Device Regulatory Affairs
• Organizational management, technical management, and policy making skills
• Direct experience interacting with FDA, European Notified Bodies, and other regulatory bodies
• Ability to communicate effectively, orally and in writing
• Ability to travel to meet with customers, suppliers, and other stakeholders

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship