Regulatory Affairs Advisor

Role Overview

• Plays a key role in supporting the development of regulatory strategy on behalf of the regulatory affairs team across Natera’s products and services.
• Combines strong technical knowledge and understanding of regulatory requirements within at least one regional expertise, e.g. US FDA, CAP/CLIA/NYS, EU, or Japan to support the approval and registration of Natera’s products and services.
• Represents the RA team to internal and external stakeholders through written and verbal communication within at least one product line.
• Maintains product registrations, change assessments and post-market surveillance reports and records of communication with regulatory authorities.
• Supports overall effectiveness of the regulatory affairs team at Natera through contributions to staff development, process improvements and understanding of current regulatory requirements.

Requirements

• Education: Bachelor’s degree in life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred.
• Certification: RAC preferred.
• Experience: Minimum of 12 years of direct applicable regulatory experience in medical devices.
• Specialized Experience: IVD experience and CDx a plus; PMA experience preferred.
• Management: Minimum of 5 years managerial experience preferred.

Benefits

• Competitive Benefits
• Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits.
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more.
• We also offer a generous employee referral program!