Regulatory Affairs Specialist

Regulatory Affairs Specialist

Baxter International

Remote, Italy

WHAT YOU'LL BE DOING:

• 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

WHAT YOU'LL BRING:

• 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