Job Summary In this position, you will be the back-up of the head of the device team. You will be in charge of proposing some transversal activities to support innovation, strategic partnership and/or continuous improvement. Processes. Responsibilities / Duties :
* 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.
* Deliver products DHFs in compliance with defined regulation (e.g. FDA 21 CFR par 820 and part 4, ISO 13485, EMA, NbO...)
* In collaboration with Regulatory Team, write submission dossier for FDA and NbO (EMA) at first. Part of the rapid response team for all device related Health Authority IRs and requirements.
* Report and tightly control device development timelines, budget and risks to biosimilars project development team, elevate to management potential issues as needed.
* Act as the main interface between the biosimilars project development teams and the medical devices sub teams (e.g. HFE, RM, Production Unit, 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.
* Identify new device opportunities.




* Lead innovation and/or Continuous improvement projects
* Support marketed products life cycle management activities such as complaints investigation, change controls activities and DHF update.
* Support labeling development with HFE, Regulatory and Marketing to ensure labels are available for HFE validation activities. Technical

skills:
* Deep technical understanding of device design, validation, verification and their link to other drug development activities (drug CMC, clinical, manufacturing, regulatory, quality, commercial, etc.) in the overall drug development plan.
* 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. Qualification and Experience

Requirements:
* 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.
* Experience in FDA regulated medical devices, Standalone CE marked devices and combination drug device products.

📌 Director Medical Device Program Lead (Madrid)
🏢 Fresenius Kabi USA
📍 Madrid