Regulatory Affairs Manager

Abbott • Lake Forest, IL

1d • $99,300 - $198,700 • Onsite

About The Position

The Regulatory Affairs Manager works at Abbott’s Lake Forest, Illinois location in the Core Lab, Diagnostics Division. The role provides regulatory review and strategic guidance for advertising and promotional materials and activities, including digital, customer-facing, and external communications supporting U.S. and global marketing initiatives. The products and solutions covered include medical devices, in vitro diagnostics, Digital Health solutions, automation platforms, software-enabled products, and select non-medical products.

The manager reviews and approves promotional materials to ensure compliance with applicable regulations, approved labeling, corporate policies, divisional procedures, and ethical business practices. The role collaborates with cross-functional stakeholders to support product claims, assess and mitigate regulatory risk, and enable compliant communications throughout the product lifecycle. Responsibilities do not include product registration activities or regulatory submissions associated with obtaining market authorization.

Requirements

• Bachelor’s degree or equivalent.
• 4–5 years of experience in a regulated industry, such as medical products or nutritionals.

Nice To Haves

• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, or pharmacology), math, engineering, or a medical field.
• M.S. in a technical area or M.B.A.
• Ph.D. in a technical area or law.
• Regulatory certification, such as RAC from the Regulatory Affairs Professionals Society.
• Regulatory experience; alternatively, experience in quality assurance, research and 2–5 years of development/support, scientific affairs, operations, or related areas may be considered.
• 2 or more years of advertising and promotion regulatory experience with medical products such as IVDs, Clinical Chemistry, and/or Pharmacology.

Responsibilities

• Provide regulatory input to product lifecycle planning.
• Assess product claims and regulatory risk, and provide guidance supporting compliant product communications and business objectives.
• Review and align product communications with applicable regulations, approved labeling, corporate policies, and divisional procedures throughout the product lifecycle.
• Support the development, maintenance, and implementation of multi-country regulatory strategies, as applicable.
• Develop strategies and recommendations on complex regulatory issues.
• Identify and assess emerging regulatory issues and regulatory changes that may affect business activities.
• Provide regulatory guidance and support to regional and country Regulatory affiliates on advertising, promotional, digital, and external communications activities, as needed.
• Interpret and apply regulatory requirements, company policies, and divisional procedures to support compliant business activities.
• Communicate regulatory risks and recommend risk-mitigation strategies to stakeholders.
• Support consistent regulatory approaches to promotional and external communications across global, regional, and local markets, as appropriate.
• Partner cross-functionally as a trusted regulatory resource, providing expertise, guidance, and knowledge sharing.
• Contribute to improving regulatory review processes, procedures, and training related to advertising and promotion activities.

Benefits

• Career development opportunities with an international company.
• Potential eligibility for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit for pursuing a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager