Associate Regulatory Affairs Director, Spine

MCRA is part of IQVIA MedTech. The Associate Director, Regulatory Affairs, Spine will support regulatory strategy and submissions for client companies. Key responsibilities include developing regulatory services, managing personnel, and communicating with regulatory bodies and clients.

Requirements

• Regulatory Submissions
• Regulatory Strategy, Analysis & Development
• Design, Review & Implement Pre-Clinical Testing
• Manage junior members of MCRA’s regulatory department
• Perform business development functions to secure new clients and projects
• Work directly with client companies and/or regulatory bodies without senior MCRA staff oversight
• Provide project leadership while maintaining sole relationship with client companies
• Work collaboratively with other MCRA departments, including clinical, RHEMA, and quality assurance

Benefits

• Paid time off
• 401k matching
• Health and welfare benefits
• Bonuses and/or other forms of compensation