Director Medical Device Program Lead

About the role

Fresenius Kabi is looking for a Director Medical Device Program Lead in Eysins, acting as backup to the head of the device team. You will propose transversal activities supporting innovation, strategic partnerships and continuous improvement, and oversee device development, validation and regulatory activities.

Key responsibilities

• Lead cross-functional exercises to define targeted device profiles and develop device development project plans and budgets with internal and external teams.
• Deliver quality products and processes with appropriate validation and regulatory documentation, in compliance with regulations such as FDA 21 CFR Part 820, ISO 13485, EMA and NbO.
• Write submission dossiers for FDA and NbO (EMA) in collaboration with the Regulatory Team, and join the rapid response team for device-related health authority inquiries.
• Control device development timelines, budget and risks, escalate issues to management, and act as the main interface between biosimilars project teams and device sub-teams and vendors.
• Analyze risks, suggest mitigation plans, and proactively alert stakeholders to risk areas.
• Identify new device opportunities, lead innovation and continuous improvement projects, and support marketed product lifecycle activities such as complaints investigation, change controls and DHF updates.
• Support labeling development with HFE, Regulatory and Marketing so labels are ready for HFE validation.

Required profile

• Bachelor's degree (or equivalent) in Product Design, Mechanical, Process, Materials Science or Electronic Engineering.
• 5+ years of project management experience.
• 10+ years of device development experience, with knowledge of device safety, regulatory requirements and procedures.
• Experience with FDA-regulated medical devices, standalone CE-marked devices and combination drug-device products.
• Fluent English, spoken and written; German or French is an asset.

Required skills

• Deep technical understanding of device design, validation and verification linked to drug development activities (CMC, clinical, manufacturing, regulatory, quality, commercial).
• Track record of resolving issues in a matrix organization.
• Solid organizational skills, attention to detail and multi-tasking.
• Strong interpersonal and communication skills with stakeholders.