Regulatory Affairs Manager - Medical Devices & IVD Promotions

Abbott

Lake Forest (IL)

On-site

USD 110,000 - 140,000

Full time

5 days ago
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Benefits offered by this job

Health benefits
Tuition reimbursement
Retirement plan with employer contrib.
FreeU education benefit
Career development opportunities

Job summary

Abbott, based in Lake Forest, IL, seeks a Regulatory Affairs Manager to provide regulatory review and strategic guidance for advertising and promotional materials across devices, IVDs, and digital health solutions. You’ll collaborate with cross-functional teams to support global marketing initiatives and maintain compliant communications throughout the product lifecycle.

The role emphasizes regulatory risk assessment, labeling alignment, and training to improve review processes.

Qualifications

  • Bachelor's degree in a related field or equivalent experience.
  • 4–5 years in a regulated industry such as medical products or nutritionals.

Responsibilities

  • Provide regulatory input to product lifecycle planning and strategy.
  • Assess product claims and regulatory risk to support compliant communications.
  • Review promotional materials for compliance with regulations and labeling.
  • Support multi-country regulatory strategies and cross-functional collaboration.
  • Identify emerging regulatory issues and advise on mitigation strategies.
  • Provide regulatory guidance to regional affiliates on advertising, digital, and external communications.

Skills

Regulatory knowledge
Communication skills
Attention to detail

Education

Bachelor's Degree
MS or MBA preferred
PhD helpful

Job description

Abbott, based in Lake Forest, IL, seeks a Regulatory Affairs Manager to provide regulatory review and strategic guidance for advertising and promotional materials across devices, IVDs, and digital health solutions. You’ll collaborate with cross-functional teams to support global marketing initiatives and maintain compliant communications throughout the product lifecycle.

The role emphasizes regulatory risk assessment, labeling alignment, and training to improve review processes.

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