Principal Regulatory Affairs Specialist – US New Product Introduction – Diabetes Care (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.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, 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

The Principal RA Specialist – US New Product Introduction will work on-site out of our Alameda, CA location 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. Our FreeStyle Libre continuous glucose monitors has revolutionized the way roughly 6 million people worldwide manage their diabetes.
This is an exciting opportunity with responsibilities for US submissions for new product introductions, which include breakthrough advancement in diabetes management and digital health technology solutions to address the spectrum of customer needs.

Projects will focus on premarket submissions for our portfolio of continuous glucose monitoring systems. Working knowledge of insulin and drug solutions for diabetes management or past experience in submitting NDA / BLA submissions is preferred. The individual has department level influence with experience in US submissions and on-market changes, and is generally recognized as an expert resource both within Abbott and externally. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.

What You’ll Work On

• Develop global regulatory strategies for product development and planning throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Provide technical leadership and strategic input on complex issues and to business units.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Create project plans and timelines.
• Lead functional groups in the development of relevant data to complete a regulatory submission.
• with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

  The base pay for this position is

  $95,500.00 – $190,900.00

  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:

  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)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: is the Law link - Espanol: #J-18808-Ljbffr