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Active1d ago

Regulatory Affairs Advisor

Natera·📍 Us-Remote, Canada

Employment

Full-Time

Work mode

Remote

Experience

SENIOR LEVEL

Salary

$146.1K – $182.6K/yr

Role overview

Job description

POSITION SUMMARY Title: Regulatory Advisor - FDA Pharma & IVDR Natera is a clinical genetic testing company specializing in non-invasive, cell-free DNA (cfDNA) and liquid biopsy testing . The Regulatory Advisor plays a key role in developing and driving regulatory strategy on behalf of the regulatory affairs (RA) team, specifically focusing on FDA Pharma and IVDR initiatives. At Natera, we remember there is a person behind every sample . This role combines strong technical knowledge and an understanding of regulatory requirements (US FDA, CAP/CLIA/NYS, EU, or Japan) to support the approval and registration of products that proactively inform disease management . You will represent the RA team to internal and external stakeholders through written and verbal communication. This role maintains product registrations, change assessments, post-market surveillance reports, and records of comm

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What they are looking for

Skills & requirements

Qualification

QUALIFICATIONS Bachelor’s degree in a 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; Regulatory Affairs Certification (RAC) preferred; All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status

Department · Regulatory Affairs

Natera logo

Hiring company

Natera

Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.

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