Software Regulatory Program Manager

Organization
Natera
Job Location
San Carlos, CA
Job Description

Natera is looking for an Agile SDLC process specialist with solid experience in achieving CE IVD and FDA software regulatory compliance. This position will be located in our San Carlos, CA headquarters.  As a key member of the software team, you will drive and own the necessary process changes to enable regulatory compliance and maintain the flexibility afforded by an agile software development lifecycle. Skills & Requirements: 

  • Deep experience with IEC 62304 and FDA Medical Device regulatory frameworks
  • Demonstrated success in achieving regulatory compliance with software developed under an agile development methodology
  • Experienced in creating software technical documentation while establishing the associated lean processes
  • Proven track record in successfully working with FDA and other regulatory bodies
  • Demonstrated experience in Continuous Process Improvement
  • Self-motivated, and detail oriented

 About NateraNatera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to help families diagnose and manage genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif., currently offering a host of preconception and prenatal genetic testing services primarily to OBGYN physicians and in-vitro fertilization centers. In 2013, the company launched Panorama™, a safe, simple test for pregnant women that screens for the most common chromosomal anomalies in a fetus as early as nine weeks of gestation. Tests developed by Natera have not been cleared or approved by the U.S. Food and Drug Administration (FDA). For more information, visit www.natera.com. Equal Opportunity Natera affords equal employment opportunities to all qualified persons, regardless of race, color, religion, national origin, age, sex, disability, sexual orientation, gender expression, veteran or marital status.

How to Apply

Please apply on the Natera website at www.natera.com or email me your resume at: derek@biotech-recruiters.com

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