/ CAREER WITH A PURPOSE /
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.
Senior Director Medical Device Program Lead (m/f/d)
With our corporate philosophy of «caring for life», we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.
In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.
Lead a team of cross functional device experts including Device project leads, Human Factor and Risk Management,... Lead definition of device development strategy in partnership with key internal stakeholders. Ensure implementation of Quality Management System within Fresenius Kabi SwissBioSim Lead cross-functional exercises to define targeted device profiles. Develop device development project plans and budget with internal and external cross functional teams. Deliver quality products and processes with appropriate validation and regulatory documentation. Report and tightly control device development timelines, budget and risks to biosimilars project development team. Act as the main interface between the biosimilars project development teams and the subteams (e.g. medical devices, manufacturing & supply, etc.) as well as device vendors. Provide technical and business inputs to projects. Analyze risks and suggest mitigation plans. Oversee device development, manufacturing, validation and regulatory activities. Proactively anticipate and identify risk areas and alert stakeholders appropriately. Report and escalate to management potential issues as needed. Identify new device opportunities
Bachelor's degree (or equivalent) in an applicable Product design, Mechanical, Process, Materials Science or Electronic Engineering field. 5+ years of experience in project management 10+ years of experience in device development with an understanding of device safety, regulatory requirements, policies and procedures. Deep technical understanding of device design, validation, verification and their link to other drug development activities (clinical, manufacturing, commercial, etc.) in the overall drug development plan. Experience in FDA regulated medical devices, Standalone CE marked devices and combination drug device products. Track record of resolving issues in a matrix organization. Strong interpersonal and relationship building skills with the ability to establish a trusted role with the various stakeholders. Solid organizational skills including attention to detail and multi-tasking skills. Effective verbal and written communication. Fluent in English, both oral and written; additional languages (German or French) are an asset. Managerial experience
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Amélie Curchod Fresenius Kabi SwissBioSim GmbH
Ref. number: 45648
At a glance
Career level: Professional Experienced
Job category: Project Management
Working condition: Permanent / Full-time
Business segment: Fresenius Kabi
Location: Eysins / International
Closing date for applications: none - we look forward to your application
Over 300,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story.
One of Fresenius' strengths:
our corporate culture for entrepreneurs in an enterprise where you can quickly take on responsibility.
The benefits we offer:
Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.
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