Full-Time
Regulatory Manager
Telehealth & in-home care provider
$119,000 - $160,000
Junior, Mid, Senior
Remote in USA + 1 more
- 5-7 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
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.
Company Stage
Later Stage VC
Total Funding
$1B
Headquarters
New York, New York
Founded
2017
6 month growth
↑ 9%1 year growth
↑ 15%2 year growth
↑ 10%Benefits
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