Specialist Regulatory Affairs
Abbott · Abbott Park, IL
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Role summary
Abbott seeks a Regulatory Affairs Specialist for the Transfusion Medicine Business in Abbott Park, Illinois. This role supports regulatory activities for medical device product development, market entry, and compliance across US and international markets.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-10-04). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- Bachelor's degree in science or medically related field
- 2-3 years experience in regulated industry such as medical devices or pharmaceuticals
- Knowledge of regulatory submission processes and requirements
- Ability to interpret and apply regulatory standards
- Strong communication skills for cross-functional collaboration
- Experience with FDA submissions or device hardware/software preferred
What you'll be doing
- Support regulatory activities for product market entry and on-market device support
- Evaluate regulatory history and develop approval strategies for US and international markets
- Compile, prepare, review, and submit regulatory submissions to authorities
- Monitor changing regulations and track applications under regulatory review
- Assess quality, preclinical, and clinical documentation for submission filing
Privacy & handoff
This role links to Abbott's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.