Senior Regulatory Affairs Specialist
Natera
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $87,900 - $109,900 per year
Job Level
Senior
About the role
- 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.
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Soft skills
guidanceregulatory strategygoal settingregulatory complianceproject deliverablesrecord keepingteam collaboration
Certifications
Associate's DegreecertificateB.A.B.S.