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 114,000 colleagues serve people in more than 160 countries.

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. Youll 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 bachelors 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 on-site at our Alameda, CA location. 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 opportunity at Lingo.

What Youll 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

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.

Review and approve advertisement and promotional material pertaining to the cleared product

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.

Required Qualifications

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.

Preferred Qualifications

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.

The base pay for this position is $86,700.00 $173,300.00. In specific locations, the pay range may vary from the range posted.