1 001 – 5 000 Қызметкерлер
H1B визасының демеушісіБиотехнологияДенсаулық сақтауМедициналық сақтандыруNatera денсаулық сақтау саласына арналған жасушасыз ДНҚ тестілері мен биоинформатикалық шешімдер әзірлейді. Компанияның диагностикалық технологиялары инвазивті емес пренаталдық скринингті, қатерлі ісікті анықтауды және ағза трансплантациясын бақылауды қолдайды. Бұл клиницистер мен пациенттерге күтім көрсету туралы неғұрлым негізделген шешімдер қабылдау үшін генетикалық ақпаратқа қол жеткізуге көмектеседі. Компанияның жұмысы заманауи медицинаның бірнеше саласында биотехнологияны, деректерді талдауды және клиникалық қолданбаларды біріктіреді.
Senior Regulatory Affairs Advisor (FDA, IVDR) - Remote, United States
Natera seeks a Regulatory Affairs Advisor to advance FDA Pharma, IVDR, and IVD strategies for its clinical genetic testing business. The role covers submissions, product registrations, regulatory guidance, and cross-functional program leadership.
Америка Құрама Штаттары146 100 $ – 182 600 $ / жыл
ҚашықтанТолық жұмыс күніАға маманЖетекшіҚажетті Тіл: ағылшын тіліСәйкестікСипаттама
- Represent Regulatory Affairs on assigned cross-functional teams
- Engage customers and regulatory authorities on regulatory pathways, performance claims, supporting evidence, and submission or registration labeling
- Develop and implement regulatory strategies for complex programs, with emphasis on FDA Pharma, IVDR, and IVD systems
- Pursue efficient product clearance and approval pathways while maintaining compliance with applicable regulations
- Coordinate and prepare submissions with limited supervision, including EU/IVD/IVDR technical documentation, classification requests, pre-submissions, 510(k) notifications, investigational device exemptions, NYS Department of Health submissions, and global registrations
- Mentor Regulatory Affairs associates and contribute to their professional development
- Provide regulatory training to internal teams
- Lead cross-functional initiatives involving regulatory changes, new registration requirements, and process improvements
- Support individual and department objectives aligned with business priorities
- Assess advertising, promotional materials, and labeling for regulatory compliance across a shared product line
- Identify process deficiencies and develop data-driven improvements
- Assess the global regulatory submission impact of product changes
- May supervise small teams
- Maintain product registrations, change assessments, post-market surveillance reports, and records of communications with regulatory authorities
Талаптар
- Bachelor's degree in a life sciences discipline or equivalent experience
- At least 8 years of directly relevant regulatory experience in medical devices, laboratory-developed tests, or pharmaceutical products
- Working knowledge of U.S. and EU medical device, IVD, IVDR, FDA Pharma, and/or laboratory-developed test regulations
- Background in continuous improvement, project management, and product development processes
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Capacity to manage multiple projects and consistently deliver results
- Ability to develop and lead organizational change
- Strong written and verbal communication skills, including cross-cultural communication and regulator negotiations
- Advanced life sciences degree and/or MBA preferred
- Regulatory Affairs Certification preferred
- Extensive experience with FDA Pharma and IVDR submissions highly preferred
- Experience in Organ Health or Women's Health diagnostics strongly preferred
- In Vitro Diagnostics and Companion Diagnostics experience is advantageous
- PMA experience preferred
Артықшылықтар
- Comprehensive medical, dental, vision, life, and disability coverage for eligible employees and dependents
- Complimentary testing for employees and their immediate families
- Fertility care support
- Pregnancy and baby-bonding leave
- 401(k) plan benefits
- Commuter assistance
- Employee referral program