Regulatory Affairs Specialist - Temporary Role
Remote · Italy
Job Summary
Regulatory Affairs Specialist responsible for providing regulatory input to new product development and lifecycle planning for Global Surgical Solutions (Operating Lights, Operating Tables, and Accessories), generating documentation and procedures for product development and quality control in accordance with regulatory standards (21 CFR 820, MDR, ISO 13485), maintaining DHF/Technical Documentation, managing regulatory submissions for Medical Devices (Class I & II), overseeing document control and archiving, coordinating with cross-functional teams, and ensuring compliance with post-marketing requirements and recalls. Requires 1–2 years of international regulatory submission experience or equivalent >5 years in medical device/GMP environments, strong project management, and excellent English communication. Baxter is an equal opportunity employer with accommodations available.
Required Qualifications
- Completed academic education in a related medical, science, engineering services, or regulatory discipline required
- Minimum of 1-2 years experience in creating and managing international regulatory submissions for Medical Devices (Class I & II preferred) or more than 5 years in the medical device industry or related GMP environment or equivalent
- Specific medical device experience, particularly with Class I and Class II hardware developed devices
- Global Registration experience with Medical Devices
- First Project Management Experience
- Strong proficiency with Microsoft systems (Excel, PowerPoint, Word, Teams, Sharepoint, Copilot)
- Excellent English communication skills
- Ability to work in cross-functional teams with people from various disciplines and cultures
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