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