Senior Specialist, Regulatory Affairs
3 weeks ago
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.
Experienced in medical devices With direction, develop and execute regulatory project plans Identify and elevate key areas of regulatory risk Maintain current knowledge of international regulatory requirements, guidance and standards applicable to company products Participate as an active team member and provide regulatory advice to project teams as required Respond to questions from regulatory authorities within strict timelines Compile and submit, in a timely manner, regulatory documents according to regulatory requirements Maintain and update existing regulatory authorizations Support regulatory activities relating to specific portfolio of products/projects Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations Prepare SOPs to reflect specific local requirements. Review advertisement and promotional literature when needed Represent or lead Regulatory Affairs in small project teams Provide guidance to junior team members when needed Perform other duties as assigned Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs). Oversee documentation to ensure completion of records and GDP Compliance Prepares SOP, Document Change Request (DCRs) and Periodic Review. Ensure compliance with SOPs, quality assurance, internal and local regulations and GDPMDS (GDP for Medical Devices) standards.Work Knowledge / Skills Required
Well-versed with new registration, license extensions, variations and renewals. Experience with Class II devices onwards is mandatory. Knowledge of applicable regulatory laws and acts and well-versed with changing scope and evolving regulations Good understanding of GDPMD Project management skills Manage multiple projects and deadlines Ability to multitask and prioritize Interpersonal and communication skills Negotiation skills Technical system skills (e.g. word processing, spreadsheets, databases, online research) Ability to identify compliance risks and escalate when necessary-
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