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Regulatory Specialist
Confirmed live in the last 24 hours
Remote • New York, NY, USA
Experience Level
  • 4-5 years of relevant diagnostic/device industry experience with experience developing and executing regulatory strategies and product development of 510(k) devices
  • Experience in regulatory, development, clinical, quality, and or program management in IVDs and medical devices
  • Experience preparing and submitting regulatory submissions including IDEs, 510(k)s, and pre-submission requests
  • Thorough working knowledge of FD&C Act and CLIA and implementing regulations
  • B.S./B.A. in science, engineering, or related technical field; advanced degree preferred
  • Experience with quality systems activities (21 CFR 820/ISO 13485) preferred
  • Regulatory Affairs Certification preferred (e.g., RAPS)
  • Provides regulatory support to currently marketed medical device products and new product development initiatives/launches by advising on FDA requirements, e.g., label/labeling, advertising and promotion (e.g., claims development), device classification and regulatory strategy to market. This includes partnering with the Quality and Innovation, Research and Development team
  • Reviews and provides regulatory input on analytical and clinical study protocols intended to support the safety and effectiveness/performance of a device
  • Owns and manages submission activities for a variety of device regulatory applications, including IDEs, 510(k)s, pre-submission requests
  • Acquires and maintains current knowledge of applicable regulatory requirements, including IVD regulations and scientific/technical principles
  • Partners with existing lab scientific/compliance leaders to ensure compliance with laboratory regulations and accreditation (CLIA, CAP)Interfaces with regulatory authorities on regulatory and technical matters

201-500 employees

Telehealth & in-home care provider
Company Overview
Ro's mission is to revolutionize healthcare by building accessible, impactful, and trusted care that people want. The company provides high-quality, affordable healthcare without the need for insurance through their vertically integrated platform that powers a personalized, end-to-end healthcare experience from diagnosis, to delivery of medication, to ongoing care.
  • Medical, dental, & vision benefits
  • One Medical membership
  • Equity
  • Flexible Time Off
  • Gym reimbursement stipend
  • Learning & development stipend
  • Paid parental leave
  • Flexible work arrangements
  • Dog-friendly office
  • Company-wide events
Company Core Values
  • We treat patients for life
  • Take on the complexity for out patients
  • Meet patients at eye level
  • Transparency drives better outcomes
  • Always look under the rock
  • Progress over perfection