Senior Regulatory Affairs Specialist

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:

Senior Regulatory Affairs Specialist

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.

The Opportunity

The position of Senior Regulatory Affairs Specialist is within our Toxicology Business Unit located in Pomona, CA. This role is responsible for directing and coordinating the implementation of regulatory compliance programs as required by federal, state, and local government agencies. This includes achieving government registration and licensure approval of new products and assuring that current products and manufacturing operations are in compliance with applicable regulations. You will interact with Marketing, Sales Regional Regulatory Affairs staff, regional distributors, governmental regulatory agencies and other third-party accrediting bodies. 

What You’ll Work On

• Provides regulatory support for commercial in-vitro diagnostic products  

• Performs regulatory assessment for changes made to the on-market products

• Understanding of the US 510(k) and EU CE mark (MDR/IVDR) regulatory requirements

• Develops regulatory strategies to achieve clearance/approval internationally (outside United States)

• Compiles and publishes all material required for submissions, license renewals, and annual registrations 

• Works with governmental regulatory agencies and other third-party accrediting bodies 

• Maintains approvals/licenses/authorizations for existing marketing authorizations

• Adds and maintains information contained in the Global Regulatory Information Database

• Provides recommendations on labeling, for regulatory compliance 

• Develops internal procedures and tools

• Conducts informational or training sessions for stakeholders

• Organizes and maintains hard copy and electronic department files

• Keeps informed of global regulatory information

• Carries out duties in compliance with established business policies

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices

• Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

• Performs other duties and projects as assigned

Required Qualification

• Bachelor’s degree (BS/BA) in a scientific field

• 3-5 years of experience in a regulated industry

• Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio

• Able to work on multiple tasks as a team member and/or ability to operate as an