Regulatory Affairs Specialist – Temporary

Baxter International Inc.

Regulatory Affairs Specialist providing regulatory input for Global Surgical Solutions at Baxter. Collaborating with teams to ensure compliance and manage submissions for medical device products.

Posted 5/27/2026full-timeRemote • 🇮🇹 ItalyJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

Provide regulatory input to new product development and product lifecycle planning mainly for Global Surgical Solutions product portfolio (Operating Lights, Operating Tables and Accessories)
Generation of documentation and procedures relating to product development, manufacturing, and quality control in accordance with regulatory standards
Ensure compliance with regulations (e.g. 21 CFR 820, MDR), standards (ISO 13485), and the quality manual and internal procedures.
Work closely with product development, clinical, and marketing teams to gain required information for new product submissions and provide regulatory advice to project teams as required (Example: DHF/Technical Documentation maintenance)
Review documents, including Clinical Evaluation reports, risk analysis, FMEA, reports, labeling, advertising, promotion and marketing literature
Assist with document control, including document review, approval, archiving, maintenance of document list, and working with other functional groups on development of new processes or procedures
Maintain regulatory files in a format consistent with requirements
Assess the acceptability of quality, preclinical and clinical documentation for regulatory submission filing
Monitor applications under regulatory review
Communicate application progress to internal stakeholders
Communicate preapproval compliance activities
Ensure compliance with product post-marketing approval requirements
Ensure external communications meet regulations
Identify emerging issues for Regulatory Compliance
Provide regulatory input for product recalls, recall communications, and CAPAs, (where necessary)
Provide MDR updates/guidance to product development teams

Requirements

What you’ll need

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, ideally with supporting new product developments and launches
Strong proficiency with Microsoft systems (Excel, PowerPoint, Word, Teams, Sharepoint, Copilot)
Strong attention to detail as well as strong questioning and listening skills
Good planning and organizational skills and the ability to organize and track complex information
Analytical and problem-solving skills
Strong internal customer service orientation with “do whatever it takes” attitude
Excellent English communication skills
Ability to work in cross-functional teams with people from various disciplines and cultures
Review technical documents

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible working hours
Paid time off
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory inputproduct lifecycle planningdocumentation generationquality controlregulatory compliancerisk analysisFMEAregulatory submissionsmedical devicesproject management

Soft Skills

attention to detailquestioning skillslistening skillsplanning skillsorganizational skillsanalytical skillsproblem-solving skillscustomer service orientationcommunication skillsteam collaboration