Regulatory Affairs Manager, Diagnostics & Digital Health

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

Job summary

Abbott in Lake Forest, IL seeks a Regulatory Affairs Manager to provide regulatory review and strategic guidance for advertising and promotional materials across U.S. and global marketing initiatives for medical devices and IVDs.

You will collaborate with cross-functional teams, assess regulatory risk, and enable compliant communications throughout the product lifecycle. This role emphasizes adherence to regulations, labeling, and corporate policies, with travel as needed.

Qualifications

• Bachelor's Degree (or equivalent).
• 4–5 years’ experience in a regulated industry (e.g., medical products).
• Bachelor’s degree in science or engineering preferred.
• MS or MBA preferred.
• PhD helpful; RAC certification a plus.
• 2+ years in Ad/Promo regulatory experience with IVDs/Clinical Chemistry/Pharmacology.

Responsibilities

• Provide regulatory input to product lifecycle planning.
• Review and approve promotional materials to ensure compliance with regulations and labeling.
• Support multi-country regulatory strategies and regional affiliates as needed.
• Identify regulatory risks and advise on mitigation strategies.
• Collaborate cross-functionally to align regulatory approaches across markets.

Skills

Regulatory strategy

Advertising/Promotions regulation

Cross-functional collaboration

Regulatory risk assessment

Education

Bachelor's degree or equivalent

MS or MBA preferred

PhD helpful

RAC certification helpful

Job description

Abbott in Lake Forest, IL seeks a Regulatory Affairs Manager to provide regulatory review and strategic guidance for advertising and promotional materials across U.S. and global marketing initiatives for medical devices and IVDs.

You will collaborate with cross-functional teams, assess regulatory risk, and enable compliant communications throughout the product lifecycle. This role emphasizes adherence to regulations, labeling, and corporate policies, with travel as needed.