Regulatory Specialist

IVD/Clia

Confirmed live in the last 24 hours

Locations

Remote • New York, NY, USA

Experience Level

Entry

Junior

Mid

Senior

Expert

Requirements

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)

Responsibilities

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

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.

The Role

We’re looking for a FDA regulatory specialist 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:

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)

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 $92,000 to $124,500, 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.

See our California Privacy Policy here.

201-500 employees

Website

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.

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

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