Senior Regulatory Affairs Specialist – Lingo (on-site)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: • Career development with an international company where you can grow the career you dream of. • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. • An excellent retirement savings plan with high employer contribution • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. ABOUT LINGO Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health. THE OPPORTUNITY Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. This is an exciting on-site opportunity at Lingo in Alameda, CA.  What You’ll Work On   • Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices • Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance • Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input. • Assist with promotional content development and review for compliance before distribution. •  Lead Regulatory Affairs Ad & Promo SOP development and review. • Prepares robust regulatory applications/submissions to regulatory authorities. • Assist in SOP development and review in support of "next-gen" product offerings. • Evaluate proposed design, labeling, and distribut