Regulatory Affairs Operations Specialist I

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:

About Abbott 

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. 

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. 

Job Description 

WHAT YOU’LL DO 

We are recruiting for a Regulatory Operations Specialist I, to join our team in the Sylmar, CA location. In this role, you will be responsible for specialized level work assignments and/or analyses, evaluation, preparation, and management of global regulatory product releases and general support of global regulatory activities. 

Responsibilities: 

Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives. 

• Responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs) and tender support and overall regulatory operations activities. 

• Provide support for Product and Country Experts in the set-up for release of new and modified products globally. 

• Acts as a regulatory representative responsible for review and analysis of GTS blocked orders, providing guidance and direction on regulatory compliance. 

• Reviews and evaluates customer service requests and monitoring of email box for such requests, maintaining a high level of service and follow through on all communications. 

• Ensure communications convey all necessary detail and adhere to applicable regulatory standards. 

• Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates and IT. 

Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Man