As the Director of Quality Assurance and Regulatory Affairs at LifeBell AI, you’ll be responsible for all aspects of our quality assurance and regulatory affairs functions, from strategy to execution. This includes the development and implementation of quality management systems, handling filings and interactions with the FDA, ensuring regulatory compliance, and identifying reimbursement pathways for LifeBell’s products through CMS and commercial payers.
Joining now provides a unique opportunity to design and build these critical functions from the ground up, and drive a work culture committed to compliance, quality, and customer focus. In this role, you'll work closely with our COO, CTO, product lead, data scientists, and engineering teams. You’ll join a tight-knit group that values collaboration, continuous improvement, and solving challenging technical and product problems in an emerging space. Plus, we like to have fun along the way.
LifeBell AI creates intelligent software that saves lives by harnessing the latest advances in machine learning, analytics, and sensor technologies across healthcare. We’re a fully funded, fast-growing startup that is preparing for our first commercial product launch. Join us in our mission to reduce morbidity and mortality from sepsis, a life-threatening condition that affects over 48 million people globally each year. Partners include top healthcare and academic institutions.
LifeBell AI is founded and led by Erez Goren and Gari Clifford, PhD. Erez was previously the founder & CEO of Radiant Systems (NASDAQ: RADS, acquired by NCR for $1.2B), BlueCube Software (acquired by RedPrairie), and Hi-Rez Studios (70M+ players worldwide). Gari is the Chair and Professor of Biomedical Informatics at Emory University, and a Professor of Biomedical Engineering at Georgia Tech. Gari was previously an Associate Professor at the University of Oxford and a Principal Research Scientist at MIT where he commercialized multiple biomedical innovations, and managed a project to collect and analyze the world's largest public database of hospital data, MIMIC II.
What You'll Do
- Create regulatory and quality assurance strategies, and lead from inception to execution
- Draft and review regulatory submissions, and manage interactions with the FDA
- Design and develop a quality management system from the ground-up that includes complaints, CAPA, NCMR, audits, change controls, and document controls
- Ensure compliance with applicable regulations and laws from US health authorities
- Manage verification and validation of system requirements, traceability, and testability
- Train teams on risk management and regulatory practices, and embed into our culture
What We're Looking For
- 8+ yrs. experience in regulatory affairs or quality assurance at medical device companies
- An established track-record in taking products through first submission to FDA approval
- Experience building regulatory systems for hardware & SaMD (IEC 62304, IEC 60601-1)
- Experience developing quality management systems, from design to implementation
- Experience with ISO 13485, ISO 14971, 21 CFR part 820 & part 11, and ISO 9001
- Team player, who can work and communicate effectively with others
- Self-motivated, with a genuine interest in the problems you’ll be solving
- Experience in interacting with the FDA, CMS, and other health authorities
- Experience with 510(k) and De Novo pathways
- Experience with MDD/MDR
- An advanced science, technical, or business degree (BS, MS, PhD, MBA, etc.)
- Familiar with clinical or healthcare settings such as the ED, or other hospital environment
- Familiar with machine learning, analytics, engineering, or related technical disciplines
Benefits & Perks
- Competitive salary with health, dental and vision insurance
- Generous vacation, sick day, holiday, and leave policies
- Equity incentive plan and 401K matching
- Gym membership, snacks & drinks, and a casual dress style
- Opportunity for meaningful impact in a team-based environment
- Remote-friendly culture with daily stand-ups, virtual lunches, and a video-first attitude
- Self-funded, stable technology startup with an approachable leadership team
- Work-life balance and team-activities
Core Values at LifeBell AI
- Save Lives: Improving patient health outcomes is our north star
- Innovate: Our goal is to create industry defining moments, through technology & science
- Be Human: We treat ourselves, and each other, with respect & understanding
- Aim for Excellence: We push ourselves, and each other, to improve every day
- Less is Better: Focus and simplicity matter - we aim to do a few things exceptionally well
- Get it Done: Actions speak louder than words, and execution is key
Come As You Are: We aim to build an inclusive workforce. If you’re passionate about this role, but do not meet all of the qualifications listed above, we still encourage you to apply. We are an equal opportunity employer and celebrate diversity. We do not discriminate on the basis of age, ancestry, citizenship, color, ethnicity, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or invisible disability status, political affiliation, veteran status, race, religion, or sexual orientation.
Remote Work: We hire remotely from anywhere in the United States. We know great talent is everywhere, and want to build the best team we can. You do not need to relocate to Atlanta GA for this role. We do have periodic company retreats and team-events that include remote employees, which may involve occasional travel. These events are intended for your benefit, as an opportunity to connect more deeply with others.
COVID-19: LifeBell AI is committed to hiring during the pandemic, with all interviewing and onboarding done virtually. We’ve implemented various practices to make remote working as enjoyable and practical as possible. Coming to the office is entirely voluntary for team members.
Posting: If you are a recruiter or placement agency, please do not submit unsolicited resumes to our team unless we have a prior agreement. LifeBell is not liable for and will not pay for any placement fees associated with unsolicited resumes. Thank you.