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Regulatory Manager (IVD/CLIA)

Modern Fertility

Modern Fertility

Legal
Remote · New York, NY, USA
Posted on Saturday, January 7, 2023
Who We Are
Ro is a direct-to-patient healthcare company with a mission of helping as many patients as possible achieve their health goals. Ro is the only company to offer telehealth care, at-home diagnostic testing, labs, and pharmacy services nationwide. This is enabled by Ro's vertically integrated platform that helps patients achieve their goals through a convenient end-to-end healthcare experience spanning from diagnosis, to delivery of medication, to ongoing care. Since 2017, Ro has helped millions of patients in nearly every single county in the United States, including 98% of primary care deserts.
Ro was recognized as a CNBC Disruptor 50 in 2022, listed by Inc. Magazine as a Best Place to Work in 2022 for our third consecutive year, and named one of FORTUNE's 2022 Best Medium Workplaces.
We’re looking for an FDA regulatory affairs, manager to join the growing legal team. In this role, you will be the primary point of contact for in vitro diagnostic (IVD) and specimen collection kit-related matters, including assisting with product development, classification questions, regulatory submissions, if applicable, as well as reviewing label/labeling, advertisement, promotional, and other customer-facing materials for compliance with FDA regulations and guidelines. Further, you will be advising on questions related to compliance with laboratory regulations such as CLIA requirements.
You will be part of the dynamic FDA practice where you will be a key partner in making diagnostic testing more accessible.

What You’ll Do:

  • 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

What You’ll Bring:

  • 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)

We’ve Got You Covered:

  • Full medical, dental, and vision insurance + OneMedical membership
  • Healthcare and Dependent Care FSA
  • 401(k) with company match
  • Flexible PTO
  • Wellbeing + Learning & Growth reimbursements
  • Paid parental leave + Fertility benefits
  • Pet insurance
  • Student loan refinancing
  • Virtual resources for mindfulness, counseling, fitness, and physical therapy
The target base salary for this position ranges from $119,000 to $160,000, in addition to a competitive equity and benefits package (as applicable). When determining compensation, we analyze and carefully consider several factors, including location, job-related knowledge, skills, and experience. These considerations may cause your compensation to vary.
Ro recognizes the power of in-person collaboration, while supporting the flexibility to work anywhere in the United States. For our Ro’ers in the tri-state (NY) area, you will join us at HQ on Tuesdays and Thursdays. For those outside of the tri-state area, you will be able to join in-person collaborations throughout the year (i.e., during team on-sites).
At Ro, we believe that our diverse perspectives are our biggest strengths — and that embracing them will create real change in healthcare. As an equal opportunity employer, we are committed to building an inclusive environment where you can be you.
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