Company: Abbott
Location: Plymouth, MN, United States
Type: Full-time | Regulatory Affairs
Salary: ~$102,935/year
About the Role
Abbott is seeking a Regulatory Affairs Specialist to ensure regulatory compliance for medical devices and diagnostics across global offices in the US, Europe, and Asia.
Key Responsibilities
- Prepare and manage regulatory submissions (510(k), CE marking, international)
- Maintain device registrations and listings across multiple markets
- Support product development with regulatory input and strategy
- Coordinate with regulatory agencies on submissions and inquiries
Requirements
- Bachelor’s degree in life sciences or engineering
- 3+ years of regulatory affairs experience in medical devices
- Familiarity with FDA eSubmitter and global regulatory frameworks
Apply: View on Abbott Careers