Regulatory Operations Specialist III – Digital Health Technologies (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

This Regulatory Operations Specialist III will work on-site at 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.

The Opportunity

As an individual contributor, the function of a Regulatory Affairs Specialist III is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and play a consultative role by partnering across business functions.  The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of digital products worldwide.  The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation. This is an exciting opportunity to work in the dynamic and evolving digital health space.

What You’ll Work On

• As an individual contributor, the function of a Regulatory Affairs Specialist III is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
• May execute tasks and play a consultative role by partnering across business functions.
• May assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of digital products worldwide.
• The individual may prepare documentation needed for registration worldwide or may oversee such preparation.
• Provide regulatory input to digital product lifecycle planning.
• Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
• Determine trade issues to anticipate regulatory obstacles.
• Determine and communicate submission and approval requirements.
• Participate in risk-benefit analysis for regulatory compliance.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Compile, prepare and review regulatory submission to authorities.
• Monitor impact of changing regulations on submission strategies.
• Monitor applications under regulatory review.
• May monitor and submit applicable reports to regulatory authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Negotiate and interact with regulatory stakeholders during the development and review process to ensure submission approval.
• Assist compliance with product post-marketing approval requirements.
• Assess external communications relative to regulations.
• Review regulatory aspects of con