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Senior Regulatory Affairs Specialist
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$120,691 - $150,864 a year
Full-time
- Senza, Senza II, Senza Omnia, and Senza HFX iQ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy.
- HFX iQ, Nevro’s latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief using each patient's response 1.
- The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
- Experience in reviews of Engineering, electrical, software/firmware, manufacturing, sterilization, marketing, labeling, and clinical documents for regulatory compliance.
- Experience working with Class III medical devices (PMA, IDE, EU MDR)
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