Regulatory Affairs Specialist II - 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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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.

A New Category of Consumer Biowearables: Meet Lingo - YouTube

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 Regulatory Affairs Specialist II will support manufacturing/operations day-to-day activities for change control in the US on-site at our Alameda, CA location. Additionally, will provide regulatory direction on team activities and apply basic regulatory understanding to support products and teams. This new team member prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide as well as handles regulatory activities involved in documentation, labeling, field support. This is an exciting opportunity at Lingo. 

What You’ll Work On

• Represent Regulatory Affairs on cross functional project teams and provide 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.
• Follows through on submission related activities to secure product approval.
• Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences.
• Provides solutions to a variety of problems where analysis requires moderate degree of evaluation.
• 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
• Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.
• Obtains supervisory regulatory review on submission documents prior to submission to government agencies.
• Ensure compliance with product post marketing requirements
• Review product labeling to ensure compliance with relevant regulatory requirements.

Required Qualifications

• Bachelor's Degree or an