Regulatory Affairs Advisor
Natera
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $146,100 - $182,600 per year
About the role
- 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.
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!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategyregulatory requirementsproduct registrationchange assessmentpost-market surveillanceIVD experienceCDx experiencePMA experiencelife sciencesmanagerial experience
Soft Skills
communicationstakeholder engagementstaff developmentprocess improvementteam effectiveness
Certifications
RAC