Senior Regulatory Affairs Specialist

📋 Description

• Understands and interprets U.S. and international medical device and in vitro diagnostic device
• Provides guidance on requirements to product development teams.
• Develops strategies for submissions to FDA and other regulatory agencies.
• Provides risk assessments and regulatory options.
• Prepares U.S. regulatory submissions necessary for new product market clearance/approval and
• Prepares and/or compiles information required by ex-U.S. regulatory associates to register or

🎯 Requirements

• Bachelor's degree or equivalent; degree in biological sciences, chemistry, or related science
• Minimum 5 years of experience in the device/diagnostic, biologic and/or pharmaceutical industry

🎁 Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and
• Natera employees and their immediate families receive free testing in addition to fertility care
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much
• Generous employee referral program.