Specialist Regulatory Affairs
Abbott Laboratories
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 5 days ago
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