Regulatory Strategy Manager, Medical Devices & IVDs

Abbott; Lake Forest (IL); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott, located in Lake Forest, IL, seeks a Regulatory Affairs Manager to guide advertising and promotional materials across U.S. and global marketing initiatives for diagnostics and medical devices.

The role emphasizes collaboration with cross-functional teams, development of regulatory strategies, and risk mitigation throughout product lifecycles, without handling market authorization submissions.

Qualifications

• Bachelor’s degree required; 4-5 years’ experience in a regulated industry.
• Experience in regulatory review of advertising and promotional materials, including digital communications.
• Familiarity with medical devices, IVDs, Digital Health, and global regulatory strategies preferred.

Responsibilities

• Provide regulatory input to product lifecycle planning.
• Review promotional materials for regulatory and labeling compliance.
• Develop multi-country regulatory strategies and communicate risk mitigation.
• Offer guidance to regional affiliates on advertising, digital and external communications.
• Collaborate cross-functionally to support compliant communications across markets.
• Contribute to continuous improvement of regulatory review processes.

Skills

Regulatory knowledge

Regulatory affairs

Education

Bachelor’s degree in science or related

M.S. or MBA preferred

Job description

Abbott, located in Lake Forest, IL, seeks a Regulatory Affairs Manager to guide advertising and promotional materials across U.S. and global marketing initiatives for diagnostics and medical devices.

The role emphasizes collaboration with cross-functional teams, development of regulatory strategies, and risk mitigation throughout product lifecycles, without handling market authorization submissions.