Director Medical Device Program Lead

Fresenius Kabi USA; Madrid; On-site; EUR 90,000 - 130,000; Full time

Job summary

Fresenius Kabi USA seeks a senior device development professional to back-up the head of the device team. You will lead cross-functional efforts to shape device profiles and drive quality, regulatory readiness, and lifecycle management for biosimilar-related projects.

You will collaborate with Regulatory, HFE, Production, and external partners to deliver DHFs, manage timelines and budgets, and identify opportunities for continuous improvement and innovation across the device portfolio.

Qualifications

• Bachelor’s degree in engineering or an equivalent field.
• Minimum 5+ years in project management.
• 10+ years in device development with regulatory understanding.
• Experience with FDA regulated devices and CE/EMA regulatory pathways.

Responsibilities

• 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.
• 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.

Skills

Device design & development

Regulatory knowledge

Cross-functional collaboration

Project management

Risk assessment & mitigation

Education

Bachelor’s degree in Engineering or equivalent

Job description

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.