Natera logo
Natera

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

Senior Regulatory Affairs Specialist

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

Location

United States

Posted

85 days ago

Salary

$87.9K - $109.9K / year

Seniority

Senior

Associate Degree4 yrs expExperience acceptedEnglish

Job Description

• Support preparation of 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. • Contribute to the setting of individual and departmental annual goals aligned with business objectives. • Review and ensure regulatory compliance of advertising, promotion and labeling across a common product line. • Support regulatory affairs efforts in new and existing technology project teams to implement regulatory strategy and meet regulatory requirements towards overall success of the project deliverables. • Support regulatory deliverables on behalf of internal and external program teams. • Build specialized knowledge of regulatory guidelines and requirements within one or more fields applicable to Natera; maintain excellent records of regulatory interactions and reports, contribute to the effectiveness of the RA team.

Job Requirements

  • 4-6 years biotech industry experience
  • Associate's Degree / certificate, B.A., B.S., or equivalent. Work experience may be considered in lieu of education.

Benefits

  • Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
  • Free testing for employees and their immediate families.
  • Fertility care benefits.
  • Pregnancy and baby bonding leave.
  • 401k benefits.
  • Commuter benefits.
  • Generous employee referral program.

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