Principal Specialist, Regulatory Affairs
Baxter · Round Lake, IL
RegulatoryFull-time$104k–$143kCompany career page
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Role summary
Principal Specialist in Regulatory Affairs at Baxter managing medical device product compliance and market access across US, EU, and global markets. Develops regulatory strategies, assesses product changes, and supports submissions throughout the device lifecycle while collaborating with cross-functional teams.
What they're looking for
- Bachelor's degree in scientific or engineering discipline
- 5+ years medical device industry regulatory experience
- Experience preparing and submitting 510(k) filings
- Knowledge of FDA change assessment guidance and EU MDR documentation
- Experience with electromechanical medical devices preferred
- Strong ability to interpret scientific information and defend submission strategy
- Ability to manage multiple projects in multinational teams
What you'll be doing
- Manage regulatory approvals, registrations, and change assessments for assigned medical device products
- Develop regulatory strategies and submission plans for product and process changes across markets
- Prepare and submit US regulatory filings including 510(k) submissions and FDA requests responses
- Maintain EU MDR documentation and support technical documentation updates
- Partner with cross-functional teams and international colleagues on global submission execution
Privacy & handoff
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