Regulatory Affairs Specialist - Remote

Overview

The regulatory affairs team at Natera is seeking a highly motivated individual to contribute to the success of Natera's women's health and organ health products. A strong background in in vitro diagnostic devices with experience working with CAP, CLIA and NYSDOH for clinical laboratory tests are highly preferred. The job involves sustaining our products in the US and worldwide through certifications, registrations, change control management, regulatory strategy and submissions to US and international agencies. Excellent collaboration skills and cross-functional written and verbal communication of regulatory requirements are sought after and honed in the role. Consider joining our team at Natera and helping to change the world of medicine.

In Short

• Contribute to regulatory plans and regulatory change assessments that meet CAP/CLIA/NYS, US IVD, EU IVDR and international requirements.
• Prepare pre-submissions to regulatory authorities providing guidance to teams on regulatory strategy and requirements.
• Support regulatory submissions for in vitro diagnostic devices including IDEs, EU/IVD Technical Documentation, classification requests, pre-submissions, and updates to registrations worldwide.
• Review and ensure regulatory compliance of advertising, promotion and labeling across a common product line.
• Collaborate within the RA team to implement least-burdensome approaches and facilitate time-to-market for Natera products and services.
• Understand and implement regulatory strategy based on existing guidance documents within a particular area of IVDs.
• Build specialized knowledge of regulatory guidelines and requirements within one or more fields applicable to Natera.
• Support RA leadership in implementation of data-driven improvements in RA processes.
• Other duties as assigned.

Requirements

• Bachelor's degree or equivalent; degree in biological sciences, chemistry, or related science strongly preferred.
• Minimum 5 years of experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs.
• Experience with molecular diagnostics and IVDs highly preferred.

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• 401k benefits and commuter benefits.
• Generous employee referral program.