Regulatory Affairs Specialist
Baxter International
Ubicación de trabajo
Milan, Metropolitan City of Milan
Estado de Empleo
Tiempo completo
Detalles de la oferta de trabajo
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
ESSENTIAL DUTIES:
• Provide regulatory input to new product development and product lifecycle planning mainly for our many Accessories for Operating Tables enabling various surgical procedures
• 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
QUALIFICATIONS:
• Completed academic education in a related medical, science, engineering services, or regulatory discipline required
• Minimum of 2-3 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)
• 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
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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