Director, Medical Device Program Lead

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🔥 0 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Fresenius Kabi

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Fresenius Kabi is a global healthcare company specializing in lifesaving medicines and medical technologies. They provide high-quality IV drugs and infusion therapies, medical nutrition (parenteral and enteral), medtech devices for anesthesia, blood donation and cell therapies, and biopharmaceuticals for autoimmune diseases and cancer. The company emphasizes quality, sustainability, global presence and support for healthcare professionals and patients worldwide.

📋 Description

• Act as back-up of the head of the device team • Propose transversal activities supporting innovation, strategic partnership and continuous improvement • Lead cross-functional exercises to define targeted device profiles • Develop device development project plans and budgets with internal and external cross-functional teams • Deliver quality products and processes with appropriate validation and regulatory documentation • Deliver product DHFs in compliance with FDA 21 CFR Parts 820 and 4, ISO 13485, EMA and NbO requirements • Write submission dossiers for FDA and NbO (EMA) with the Regulatory Team • Participate in the rapid response team for device-related Health Authority inquiries and requirements • Report and control device development timelines, budgets and risks; escalate issues to management • Interface between biosimilars project development teams, medical device sub-teams and device vendors • Provide technical and business inputs, analyze risks and suggest mitigation plans • Oversee device development, manufacturing, validation and regulatory activities • Anticipate and identify risk areas and alert stakeholders • Identify new device opportunities • Lead innovation and continuous improvement projects • Support marketed-product lifecycle management, including complaint investigations, change controls and DHF updates • Support labeling development with HFE, Regulatory and Marketing for HFE validation activities

🎯 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 • Deep technical understanding of device design, validation, verification and their link to drug CMC, clinical, manufacturing, regulatory, quality, and commercial activities • Track record of resolving issues in a matrix organization • Strong interpersonal and relationship building skills • Solid organizational skills, attention to detail and multitasking skills • Effective verbal and written communication • Fluent in English, both oral and written • Additional languages (German or French) are an asset

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