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

Our location in Irving, TX or Abbott Park, IL currently has an opportunity for a Senior Regulatory Affairs Specialist.

What You’ll Work On

• Participate as the regulatory functional product team member for the organization’s Transfusion Medicine regulatory team.

• Supports necessary regulatory activities required for product market entry and on-market support of instrument hardware and software.

• Work with Regulatory and CFT to improve efficiency in regulatory deliverables.

• Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to determine regulatory strategies for approval/clearance/registration for International and US markets for new products in development.

• Survey the organization’s country specific regulatory experts to obtain country-specific regulatory feedback during product development and at the request of the core functional product team. Compile information to provide to core functional product teams.

• Support Compliance Team in internal and external audits.

• May prepare documentation needed for registration worldwide or may oversee such preparation.

• Assist in SOP development and review.  Provide regulatory input to product lifecycle planning.

• Determine and communicate submission and approval requirements to the core functional product team.

• Participate in risk benefit analysis for regulatory compliance.

• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.

• Compile; prepare; review and submit regulatory submission to authorities (US and International).

• Monitor impact of changing regulations on submission strategies.

• Monitor applications under regulatory review. Communicate timelines and review status to the core functional product team.

• Monitor and submit applicable reports to regulatory authorities.

• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

• Assess external communications relative to applicable regulations.

• Review Advertising and Promotional material for compliance against regulatory requirements.

• Assist with label development and review for regulatory compliance before release.

• Review product changes to determine the type of change and submission requirements.

• Analyze the input of cumulative product changes to current product submissions.

• Ensure product safety issues and product associated events are reported to U.S. regulatory agencies.

• Provide regulatory input for product recalls and recall communications.

• Assess export requirements for products labeled for research or investigational use.

• Participates as a Team Member: Actively contributes to the team