Manager Regulatory Affairs

Overview

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, with 114,000 colleagues serving 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 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 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.

As the Manager, Regulatory Affairs
, the main responsibility of this role is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured or distributed to meet required regulations. The incumbent will ensure that the business complies with current standards, regulations, and industry requirements and will represent CMI RA during audits.

Regulatory Strategy & Submissions

• Develop and implement regulatory strategies to support product development and commercialization. Oversee preparation and submission of product registrations, progress reports, supplements, amendments, and periodic reports. Experience with US FDA and IVDR are a plus.

Leadership & Team Management

• Manage and mentor regulatory staff, fostering a collaborative and high-performing team. Provide regulatory guidance and support to cross-functional teams.

Compliance & Culture

• Promote a commercially aware compliance culture. Ensure adherence to harmonized standards and evolving regulations while balancing business objectives.

Regulatory Representation

• Act as delegate for Management Review when required. Serve as the primary regulatory liaison throughout the product lifecycle, including interactions with regulatory agencies to expedite approvals.

Product Development & Risk Management

• Participate in product planning, regulatory strategy development, and risk management activities. Provide expert advice on manufacturing changes, line extensions, technical labeling, and regulatory interpretations.

Change Control & Lifecycle Management

• Oversee regulatory aspects of the change control process. Ensure timely and compliant execution of product changes.

Advertising & Promotion Compliance

• Lead the Advertising and Promotional Review function within Regulatory Affairs. Collaborate with Commercial and Marketing teams to ensure compliant promotional materials.

Unique Device Identification (UDI)

• Implement and manage UDI requirements across applicable products.

Field Actions & Audits

• Support field action reporting activities as needed. Represent Regulatory Affairs during internal and external audits.

Regulatory Intelligence & Problem-Solving

• Proactively analyze regulatory feedback, identify challenges, and develop solutions to facilitate approvals and maintain compliance.

Required Qualifications

• Bachelor’s degree in Science, Math, Engineering, or medical fields.
• Minimum 5 years in a regulated industry (e.g. medical products, in vitro diagnostics). Regulatory experience preferred but may consider quality assurance, research and development, scientific affairs,…