Regulatory Affairs Advisor

📋 Description

• Represent the regulatory function on designated cross-functional teams.
• Conduct business interactions with customers and regulatory authorities regarding regulatory
• Build and execute bold, practical regulatory strategies for complex regulatory affairs programs
• Advocate for the least burdensome approaches to product clearance and approval while strictly
• Coordinate and prepare regulatory submissions with minimal supervision, including EU/IVD/IVDR
• Mentor regulatory associates and support their career advancement.

🎯 Requirements

• Bachelor’s degree in a life science field (biology, microbiology, chemistry, engineering, medical
• Regulatory Affairs Certification (RAC) preferred.
• Minimum of 8+ years of direct applicable regulatory experience in medical devices
• Direct experience with FDA Pharma and IVDR submissions is highly preferred.
• Experience in Organ Health or Women's Health diagnostics is ideal and strongly preferred.
• In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) experience is a plus.

🎁 Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and