Senior Medical Device Program Lead – Biosimilars

Fresenius Kabi; Eysins; Sur place; CHF 140 000 - 210 000; Plein temps

Résumé du poste

Fresenius Kabi Biopharma is seeking a lead for device development projects across biosimilar programs, from concept to launch. You will bridge business and technical teams, defining device profiles and managing cross-functional execution.

You will oversee regulatory activities, create DHFs, and coordinate submissions to FDA and EMA, while ensuring timelines and budgets are tightly controlled and risks are mitigated. Fluency in English is required, with German or French an asset.

Qualifications

• Bachelor's degree in engineering or equivalent field.
• 5+ years of experience in project management.
• 10+ years of device development experience with regulatory understanding.

Responsabilités

• Lead cross-functional exercises to define targeted device profiles.
• Develop device development project plans and budgets with internal and external teams.
• Deliver products with validation and regulatory documentation (DHF, FDA 21 CFR, ISO 13485, EMA).
• Write submission dossiers for FDA and NbO (EMA) with Regulatory Team.
• Manage timelines, budget and risks; escalate as needed to biosimilars teams.

Connaissances

Project management

Device development

Regulatory knowledge

Cross-functional collaboration

Risk management

Budgeting

Communication

English fluency

Formation

Engineering degree

Description du poste

Fresenius Kabi Biopharma is seeking a lead for device development projects across biosimilar programs, from concept to launch. You will bridge business and technical teams, defining device profiles and managing cross-functional execution.

You will oversee regulatory activities, create DHFs, and coordinate submissions to FDA and EMA, while ensuring timelines and budgets are tightly controlled and risks are mitigated. Fluency in English is required, with German or French an asset.