Company: Medtronic
Location: Minneapolis, MN, United States
Type: Full-time | Regulatory Affairs
Salary: ~$108,520/year
About the Role
Join Medtronic’s Regulatory Affairs team to prepare and submit regulatory documents for product approvals, maintain compliance with global regulations, and track submission progress across the portfolio.
Key Responsibilities
- Prepare and submit regulatory documents for medical device approvals
- Ensure compliance with global medical device regulations (FDA, EU MDR, etc.)
- Collaborate with cross-functional teams to support product approvals, labeling, and post-market activities
- Monitor regulatory changes and assess impact on product portfolio
Requirements
- Bachelor’s degree in science, engineering, or regulatory affairs
- 2-5 years of experience in medical device regulatory affairs
- Knowledge of FDA 21 CFR 820, ISO 13485, and EU MDR
- RAC certification preferred
Apply: View on LinkedIn