Manager Regulatory Affairs

Job Summary

A company is looking for a Manager of Regulatory Affairs - Cardiac Surgery/ACT.

Key Responsibilities:

• Lead the planning, compilation, review, and submission of regulatory filings to global health authorities
• Provide strategic regulatory guidance to cross-functional teams to support product development and lifecycle management
• Build and maintain effective relationships with global regulatory agencies and monitor relevant regulatory requirements

Required Qualifications, Training, and Education:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required
• Advanced degree (M.S., M.B.A., or related field) preferred
• A minimum of 12 years of progressive experience in regulatory affairs within an FDA-regulated industry
• Proven expertise in preparing and submitting U.S. and international regulatory filings
• Solid knowledge of medical device regulations and global regulatory requirements