Berlin, Berlin, Germany
• Drive program performance and ensure program excellence by respecting and monitoring the program KPIs during the three phases : Planning, Execution, and Closure. • Manage customer relations by analyzing needs and delivering solutions. • Negotiate and draft functional and technical documents with the Legal. • Identify further customer needs and share them with the Sales. • Lead quality process and ensure compliance with standards.
• Support the projects’ execution including creating and maintaining project schedules. • Support for the design and development of medical devices and combination products • Develop and manage a live and up to date MS Project plan for all project activities. • Leading and working with the project teams to solve challenging design. • Track quality/regulatory deliverables supporting the product’s necessary clearance. • Perform and manage Change Controls in a timely manner within the Baxter Change Control system according to the relevant procedures and guidelines • Develop an in-depth knowledge and understanding of medical device regulations with special focus on the European MDR. • Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities. • Develop an in-depth knowledge and understanding of GxP and related regulations and guidance.
• Prospecting of new technical interlocutors in English, German and French • Needs analysis with customers and URS design • Negotiation and redaction of technical and financial offers • Projects Follow Up in Automation and Process Engineering • Engineers recruitment and team management