Senior Manager of Regulatory Affairs

Job Summary

A company is looking for a Senior Manager Regulatory Affairs.

Key Responsibilities

• Leads and manages a team supporting post-market activities for medical devices and IVD products
• Prepares regulatory documentation for domestic and international submissions and registrations
• Interacts with regulatory agencies for product registrations and ensures compliance with relevant standards

Required Qualifications

• Bachelor's degree (BS/BA) in a scientific discipline
• 10 years' experience in the IVD, medical device, or bio/pharma industry
• 10 years' regulatory affairs experience with leadership progression
• Experience with regulatory documentation preparation, including 510(k) submissions and international registrations
• Prior direct interaction with FDA or other regulatory agencies