At Fitbit, our mission is to help people lead healthier, more active lives by empowering them with data, inspiration and guidance to reach their goals.
We started our journey in 2007—as a team of two with one big idea. Since then, we’ve grown to over 1,500 employees, sold over 60mm devices, and built a health and fitness community across the globe. In fact, the Fitbit Community has taken enough steps to walk from the Sun to Pluto! Offering award-winning products, a top-rated mobile app and an easy-to-use online dashboard, Fitbit provides personalized experiences that help our users reach their goals. With a reenergized focus on innovative devices, interactive experiences, and enterprise health we are transforming the way consumers and businesses see health & fitness.
From your first steps as a Fitbitter, you will be at the forefront of developing new products. Our culture combines the spirit of startup with the perks of being public. We offer a competitive benefits package and amazing perks like unlimited snacks, Friday happy hours, onsite workout classes, and a strong focus on a healthy work-life balance. As part of our team, you’ll have the opportunity to grow your career, contribute your ideas to life-changing products and services, and—above all—have fun doing it.
Fitbit’s HQ campus is located in the heart of San Francisco with office locations in Boston, San Diego and around the world. Think you’ve found your fit?
Brief description of the job:
Oversee and facilitate all Medical Regulatory Affairs functions during the development, testing, and launch of novel regulated products. Develop regulatory strategies for new or modified products while applying a risk-based approach. Act as the primary contact for the company and owner of the FDA relationship and other notified bodies. Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions. Document, consolidate, and maintain oral and written communication with FDA, notified bodies and other regulators. Evaluate information on competitive technologies as needed to identify appropriate predicates or comparable devices. Participate in FDA, notified body and other regulatory body inspections as required. Review promotional material and labeling for regulatory compliance.
What You’ll Work On:
Novel regulated products and features that will have a positive impact on the health of millions of Fitbit users.
- Minimum of a Bachelor’s degree in a life science or related field is required
- Minimum 5-7 years of experience in pre and post market medical device regulatory affairs
- Knowledgeable in US and Ex-US regulations
- Experience authoring and leading a cross-functional teams through US premarket submissions and premarket applications (i.e. 510K, de novo)
- Experience authoring Ex-US submissions including assembling and maintaining Technical File for CE mark in EU
- Familiar with regulatory pathways and experience providing strategy and guidance to new product development
- Experience providing regulatory support for products under development e.g., review engineering documents, risk analyses, requirements, test protocols and reports, Human Factors documentation, and device reporting assessments
- Experience working with, providing direction, and communicating with engineering and other cross-functional teams
- Experience managing, growing, and leading individual contributors in regulatory affairs tasks and deliverables
- Experience reporting and presenting to upper management and senior leadership
Fitbit is proud to be an equal opportunity employer. We recruit, hire, train, promote, pay, and administer all personnel actions without regard to race, color, ancestry, national origin, citizenship, religion, age, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including assumptions about a person’s appearance or behavior, gender roles, gender expression, or gender identity), sexual orientation, gender, gender identity, gender expression, marital status, medical condition, mental or physical disability, military or veteran status, genetic information or other statuses protected by law. We interpret these protected statuses broadly to include both the actual status and any perceptions and assumptions made regarding these statuses.
San Francisco applicants: Pursuant to the San Francisco Fair Chance Ordinance Fitbit will consider for employment qualified applicants with arrest and conviction records.