Senior Regulatory Affairs Associate

Job Summary

A company is looking for a Senior Regulatory Affairs Associate to support regulatory compliance for IVD products and services.

Key Responsibilities

• Support the development and execution of regulatory strategies for FDA authorization and global compliance
• Prepare and contribute to regulatory submissions, including FDA pre-submissions and EU IVDR Technical Documentation
• Collaborate with cross-functional teams to integrate regulatory requirements throughout the product lifecycle

Required Qualifications, Training, and Education

• Bachelor's or advanced degree in a relevant scientific or technical field
• Minimum of 5 years of experience in regulatory affairs within the medical device or IVD industry
• Practical experience with FDA authorization and EU IVDR submissions
• Experience with Software as a Medical Device or medical devices containing software
• Working experience in a clinical genetics laboratory is desired