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Open nowPosted yesterday

Director Medical Device Program Lead

Fresenius Kabi271 open roles

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Eysins
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Your applicationOpen nowDirector Medical Device Program LeadFresenius Kabi · Eysins

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The clock on this job

Early applications get read.

13.3% of postings close within 7 days. Measured by our own scanner across the market. Fresenius Kabi postings stay open a median of 14 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.6%3 days
  3. 13.3%7 days
  4. 21.3%14 days
  5. 35.7%30 days
  6. 59.1%60 days
This job: posted yesterday

Fresenius Kabi median: 14 days open

The posting

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, escalate 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.
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