Regulatory Affairs Specialist

Abbott • Lake Forest, CA

23h • $68,000 - $136,000 • Onsite

About The Position

Regulatory Affairs Specialist Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Lake Forest, IL location in the Core Lab , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Regulatory Affairs Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The Regulatory Affairs Specialist supports the global commercialization of In Vitro Diagnostic (IVD) devices by providing regulatory input across product development and launch lifecycles. This role partners closely with cross functional stakeholders to enable timely, compliant, and efficient market entry of internally developed or third-party products distributed by the organization. The position requires strong project planning, communication skills, and a proactive mindset focused on reducing regulatory barriers and improving processes. The individual must understand, implement, and maintain the quality policy and ensure compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Requirements

• Bachelors degree in scientific, engineering, or related discipline
• Minimum 5 years experience.
• Experience in Regulatory Affairs within the medical device and/or in vitro diagnostics industry.

Nice To Haves

• Masters degree preferred.
• Working knowledge of global regulatory frameworks applicable to IVD products.
• Demonstrated experience working in cross‑functional, matrixed project environments.
• Strong project planning, organizational, and prioritization skills with the ability to manage multiple initiatives simultaneously.
• Excellent written and verbal communication skills, with the ability to translate regulatory requirements into clear, actionable guidance.
• Proven ability to identify process improvement opportunities and drive solutions that enhance efficiency and compliance.
• Collaborative, proactive, and detail‑oriented, with a strong focus on execution and results.
• Experience supporting third‑party or externally manufactured products.
• Exposure to global product launch planning and phased international rollouts.
• Familiarity with quality systems related to product commercialization and distribution.

Responsibilities

• Provide regulatory guidance and strategic input for projects involving the global commercialization of IVD devices.
• Collaborate with cross‑functional project teams including Marketing, Commercial Quality, Technical, Regulatory Affiliates, and Third‑Party Manufacturers.
• Support project planning activities by defining regulatory deliverables, timelines, and considerations that inform launch sequencing and global launch waves.
• Ensure regulatory and quality requirements are integrated into project plans and executed in accordance with internal procedures and applicable regulations.
• Oversee regulatory aspects of launching third‑party manufactured products, ensuring adherence to internal quality systems and distribution requirements.
• Act as a regulatory liaison between internal teams and external partners to facilitate alignment, issue resolution, and timely execution.
• Identify regulatory risks and barriers early in the project lifecycle and propose mitigation strategies to support accelerated commercialization.
• Drive continuous improvement by identifying opportunities to streamline regulatory processes, improve cross‑functional workflows, and address people, process, or system inefficiencies.
• Communicate regulatory expectations, decisions, and impacts clearly to project stakeholders at varying levels of the organization.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees