We are looking for a Vice President (VP) to Lead One Drop's Regulatory Affairs (RA) and Quality Assurance (QA) for all hardware, software and blended medical devices. This leader comes with extensive experience in FDA clearance/approval, Software as a Medical Device, Medical Device with FDA as 510(k) or SaMD Device and leading IVD regulatory products.

You’ll make an impact by:

• Leading initiatives to obtain US and international regulatory clearances for new medical device products and maintain clearances for existing devices
• Advising on regulatory aspects of company strategy, regulatory assessments and classifications of potential products, and compliance readiness in different geographies
• Developing and Running One Drop’s Quality Management System, including SOP design, training, management review, documentation, tools implementation, audits & certifications 
• Building and managing a team of QA/RA professionals to execute the above

You’ll bring:

• Must have:
• 10+ years experience in Quality Assurance and Regulatory Affairs- 5+ years at a company of
• 5+ years experience managing regulatory requirements for Software as a Medical Device (SaMD)
• 5+ years people management experience
• Personally led a SaMD product to successful FDA clearance/approval, including strategy, submission drafting and/or review, and interaction with the Agency
• Personally led a “traditional” (i.e. hardware and/or IVD) medical device product to successful FDA clearance/approval, including strategy, submission drafting and/or review, and interaction with the Agency

Bonus Points: 

• Regulatory experience in a company that produces both regulated products and non-regulated, non-medical device products
• Experience with AI/ML-based Software as a Medical Device 
• Experience working in a growing startup
• Experience achieving CE Mark under MDR
• Experience leading IVD regulatory products
• Familiarity and comfort with software terminology and test strategy

You'll get:

• To deeply impact the lives of people with chronic conditions
• The opportunity to contribute at an early stage startup and help develop the future of healthcare
• Competitive salary and equity commensurate with experience and performance
• Medical, Dental, and Vision insurance and 401k plan
• Yearly Professional Development budget
• Unlimited vacation days
• Weekly catered lunches, company swag, company outings, and other surprises when you start

One Drop is the future of healthcare. Our mission is to develop technology that ensures all people living with diabetes and other chronic conditions can thrive. We harness the power of data science and mobile computing to make healthcare more affordable, accessible, and effective. 

Our clinically proven mobile platform combines AI-powered predictive insights, personalized health coaching, and FDA-approved connected devices to simplify self-care. And it works. People using the One Drop platform have seen significant improvements in their health in just a few weeks.

Today, the rate of people living with chronic conditions is increasing dramatically, and traditional approaches to healthcare cannot possibly scale to reach them all. We exist to serve those people and help them lead their best lives. www.onedrop.today

At One Drop, we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. One Drop provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. Diversity of experience and skills combined with passion is a key to innovation and excellence. Therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodations during the interview process.

To all recruitment agencies: One Drop does not accept unsolicited agency resumes. Please do not forward resumes to our jobs alias or One Drop employees. One Drop is not responsible for any fees related to unsolicited resumes.