Manager, Regulatory Affairs - Medical Device

Redwood City, CA
R&D
Led by a team with deep medical industry experience, Carrot is on a mission to save lives by leveraging technology to bring the most effective methods of smoking cessation to the masses. Carrot is a unique digital health company that has OTC carbon monoxide breath sensor that is an FDA-approved Class II medical device.  

Carrot is seeking to add its first regulatory affairs professional with expertise in managing the activities of a dynamic startup company.  This position will be responsible for a wide range of regulatory/compliance activities related to our unique health business including design (Hardware and Software) as we navigate global commercialization opportunities. You will work side by side with the Quality, R&D, Software, Clinical, Regulatory and Operation groups within Carrot to ensure that we deliver quality product to all global markets. 

This is a full-time position in our Redwood City Office.

What You'll Be Doing

    • Lead the efforts with the R&D and software teams to develop and execute global regulatory strategies that ensure timely submissions and approvals to meet company/project team objectives, goals and timelines
    • Responsible for gather/writing/preparing of regulatory content for premarket dossiers from concept through review and approval, including country registrations
    • Primary individual responsible for monitoring regulations, guidance, and regulatory or legal actions from the FDA, FTC, or competitors that may influence the regulatory landscape
    • Ensure export/import compliance for commercial and investigational devices
    • Support a variety of digital health compliance (HIPAA, GDPR) requirements

What You'll Bring

    • Medical device industry experience in a global regulatory role (FDA and OUS submissions)
    • Must have experience as the project leader/primary contact for OUS submissions (CE mark and country registrations)
    • Subject matter expert in knowledge of FDA, MDD, and ISO regulations/standards
    • The ability to perform at high-levels in a dynamic, digital health environment
    • Excellent organizational and technical writing skills
    • Preferred previous experience in regulated industry with a strong knowledge of global regulations (EU and other global markets) and their interpretation relevant to OTC/DTC products
    • Preferred prior experience in HIPAA/SOC 2/GDPR

Education

    • BA/BS degree with a minimum of 7+ years of medical device industry experience and at least 3 years of regulatory affairs experience
What We Offer:

At Carrot Inc., we'll take care of you.

In addition to competitive salaries, exciting work assignments and ample opportunities for growth, we offer medical, dental and vision insurance, stock options and generous PTO. Additionally, you will receive paid VTO (volunteer time off) to #dogood alongside your team or on your own at an organization that's close to your heart. To help you plan for the future, we also offer a 401K plan and complimentary Life- and LTD coverage.

Our office location features bay trail access to the waterway, walking and running trails, a complimentary membership to our full service gym with pool, free lunches at a world class cafe on-site, a complimentary Caltrain shuttle and close proximity to 101.

We are an equal opportunity employer and value diversity at Carrot. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.