Regulatory Affairs Advisor

12 years of direct applicable regulatory experience

IVD experience and CDx a plus; PMA experience preferred.

and EU Medical Device/IVD regulatory requirements.

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.

Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.

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.