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Natera

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

Regulatory Affairs Advisor

ComplianceComplianceFull TimeRemoteLeadTeam 1,001-5,000Since 2004H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

112 days ago

Salary

$146.1K - $182.6K / year

Seniority

Lead

Bachelor Degree12 yrs expEnglish

Job Description

Regulatory Affairs Advisor

Natera

• 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.

Job 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!

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