Research Associate Scientific III

21 May 2024

Vacancy expired!

Stefanini Group is hiring for a Research Associate Scientific III Exciting opportunity awaits! Let us help you get started. Call Aditya Yadav - (/ Job PurposeThis role is responsible for providing regulatory support for products on the market or intended to be launched into markets. Activities include data management, change assessment, variation planning, creation of data submission documentation, identification of local data submission requirements, product/facility change management, process support, and participation in project sub-teams.Summary of main job responsibilities:Support global product UDI regulatory compliance throughout the product lifecycle: Responsible for aligning with internal requirements and accountable for managing accurate UDI medical device data entered in regulated UDI databases, enabling compliance with UDI regulations in all appropriate global markets (e.g., USA, China, Europe, South Korea, Saudi Arabia) Collaborate with data management professionals, UDI data owners, and sustaining engineering resources to capture, process, and maintain UDI data in internal and external systems Represent on internal teams, collaborating on process and system development, testing, and validation Effectively communicate with all internal stakeholders (e.g., R&D, manufacturing etc.) to enable UDI compliant solution implementation and maintenance Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirementsDeliver regulatory support, as assigned: Maintain compliance with regulations (21 CFR 820), standards (ISO 13485), MDR and the Baxter Corporate Quality Manual Work closely with product development, clinical, and marketing teams to support alignment between required information for new product submissions, labeling, and UDI database entries, providing regulatory input to project teams as required (Example: DHF remediation, labeling guideline) Contribute to document management and control, including document review, approval, archiving, maintenance of document lists, and working with other functional groups on development of new processes or procedures related to UDI Timely and actively support to conclusion all associated query responses

Qualifications and skills:Proficiency with Microsoft systems (Excel, PowerPoint, and Word)Attention to detailAbility to: Communicate effectively verbally and in writing (English) Communicate with diverse audiences and personnel Manage small projects, including stakeholder, schedule, and priority management Write and review technical documents Collaborate within matrixed and/or cross-functional teams Work with people from various disciplines and cultures Actively participate and/or lead online meetings Think analytically with good problem-solving skills Organize and track complex information Exercise good and ethical judgment within policy and regulations Identify compliance risks and escalate when appropriatePrefer those who have experience and/or knowledge, including configuration requirements and testing: UDI regulatory database solutions and requirements (e.g., FDA GUDID, EU EUDAMED, etc.) SAP and/or JDE ERP systems and solutions Product and/or master data master solutions and systems (PDM, PIM, MDM)Education and experience:Required education: Bachelor's degree in a related medical, science, engineering, information technology (IT) or regulatory disciplineRequired experience: Minimum of 5 years in RA or related healthcare environment, minimum 2 years' experience with medical devices Prefer experience with UDI and/or international regulatory submissions

  • ID: #41296243
  • State: Illinois Deerfield 60015 Deerfield USA
  • City: Deerfield
  • Salary: Market
  • Job type: Contract
  • Showed: 2022-05-21
  • Deadline: 2022-07-19
  • Category: Et cetera