Regulatory Affairs Manager

Abbott • Lake Forest, CA

3d • Onsite

About The Position

The Regulatory Affairs Manager works in Abbott’s Core Lab, Diagnostics Division, at its Lake Forest, Illinois location. The position provides regulatory review and strategic guidance for advertising and promotional materials and activities, including digital, customer-facing, and external communications that support U.S. and global marketing initiatives. Relevant products 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 for 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 to obtain market authorization.

Requirements

• Bachelor’s degree or equivalent.
• 4–5 years of experience in a regulated industry, such as medical products or nutritionals.
• At least 2 years of Ad/Promo regulatory experience with medical products such as IVDs, Clinical Chemistry, and/or Pharmacology.

Nice To Haves

• Bachelor’s degree in science, math, engineering, or a medical field.
• M.S. in a technical area or M.B.A.
• Ph.D. in a technical area or law degree.
• Regulatory experience; candidates with experience in quality assurance, research and development/support, scientific affairs, operations, or related areas may also be considered.
• Regulatory Affairs Certification (RAC) or another certification.

Responsibilities

• Provide regulatory input to product lifecycle planning and assess product claims and regulatory risks.
• Review and align product communications with applicable regulations, approved labeling, corporate policies, and divisional procedures.
• Support the development, maintenance, and implementation of multi-country regulatory strategies, as applicable.
• Develop strategies and recommendations for complex regulatory issues.
• Identify and assess emerging regulatory issues and changes that may affect business activities.
• Provide regulatory guidance 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 for promotional and external communications across global, regional, and local markets.
• Partner with cross-functional stakeholders as a trusted regulatory resource, sharing expertise and guidance.
• Contribute to improving regulatory review processes, procedures, and training related to advertising and promotion activities.

Benefits

• Career development opportunities with an international company.
• Employees may qualify 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, an affordable and convenient path to earning a bachelor’s degree.

What This Job Offers

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