Senior Manager Regulatory Affairs

Overview

Role overseeing North American Regulatory Affairs for medical devices.

Ideal candidate should have 10+ years of experience in Regulatory Affairs for medical devices.

Locations

• United States, Rhode Island, Lincoln
• United States, Massachusetts, Lincoln
• United States, Massachusetts, Boston

Requirements

• 10+ years in Regulatory Affairs
• In-depth knowledge of medical device regulations
• Experience managing direct reports
• Prepared submission dossiers for FDA or Health Canada
• Experience with medical device quality processes

Responsibilities

• Develop regulatory strategy
• Compile submission dossiers
• Lead FDA pre-submission activities
• Manage regulatory specialists
• Represent Regulatory Affairs on project teams

Benefits

• Meaningful work
• Opportunities for growth
• Competitive benefits
• Paid parental leave
• Wellness stipend
• Tuition reimbursement