Senior Regulatory Affairs Specialist – Lingo (on-site)

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.

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.

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.

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. 

• 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 distribution changes for regulatory impact and implement any required regulatory action
• Utilize technical regulatory skills to propose strategies on complex issues
• Ensure compliance with product post marketing requirements
• Review product labeling to ensure compliance with relevant regulatory requirements.
• Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
• Establishes and cultivates an extensive network of support to facilitate completion of assignments.
• Influences middle management on technical or business solutions.

• Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.  
• Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.

• Advanced degree in Engineering, Sciences, or related discipline
• Previous experience with 510(k)/PMA submissions or class I / II exempt software devices
• Experience with software medical devices
• 4-6 years’ experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area.
• Ability to work effectively on cross-functional teams.
• Must be able to juggle multiple and competing priorities
• Ability to identify and solve problems and work independently with little oversight.
• Strong written, verbal, presentation, and organizational skills.
• Working knowledge of FDA QSR.
• Has a sound knowledge of a variety of alternatives and their impact on the business.