Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)

Job Description

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 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

This Senior Regulatory Affairs Specialist will work on-site out of our Alameda, CA or Milpitas, CA locations in the Diabetes Care Division. We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Opportunity

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients 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. Prior experience working with software development teams, diabetes management devices (e.g. insulin dosing algorithms), and artificial intelligence / machine learning technologies is preferred. This role will also be an important resource for the regulatory department to ensure efficient and compliant business processes. This is an exciting opportunity to work in the dynamic and evolving digital health space.

What You'll Work On

Required Qualifications

Preferred Qualifications

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.

Job Family : Regulatory Operations

Division : ADC Diabetes Care

Location : United States >

Alameda : 2901 Harbor Bay Parkway

Additional Locations : United States >

Milpitas : 1820 McCarthy Blvd

Work Shift : Standard

Travel : Yes, 10 % of the Time

Medical Surveillance : No

Significant Work Activities : Awkward / forceful / repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)