SUSONITY
Vice President, Global Program Head Healthcare(m/w/x)
Full-timeOn-siteSenior
Eysins
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20206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Eysins
Full-timeOn-siteSenior
Nejo AI Summary
Leading medical device development programs for biosimilars, defining device profiles and managing validation. 10+ years in FDA-regulated medical device development required. Central interface role across biosimilars project teams.
Requirements
- Bachelor’s degree or equivalent in Product design, Mechanical, Process, Materials Science or Electronic Engineering
- 5+ years of experience in project management
- 10+ years of experience in device development with understanding of device safety and regulatory requirements
- Deep technical understanding of device design, validation, verification and their link to drug development activities
- Experience in FDA regulated medical devices and combination drug device products
- Track record of resolving issues in a matrix organization
- Strong interpersonal and relationship building skills
- Solid organizational skills including attention to detail and multi-tasking skills
- Effective verbal and written communication
- Fluency in English; additional languages (German or French) are an asset
Tasks
- Lead cross-functional exercises to define targeted device profiles
- Develop project plans and budgets with internal and external teams
- Deliver quality products and processes with proper validation and regulatory documentation
- Report and control device development timelines, budgets, and risks
- Act as the main interface between biosimilars project teams and subteams
- Provide technical and business inputs to projects
- Analyze risks and suggest mitigation plans
- Oversee device development, manufacturing, validation, and regulatory activities
- Proactively identify risk areas and alert stakeholders
- Report and escalate potential issues to management
- Identify new device opportunities
- Lead innovation and continuous improvement projects
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 206030 Fresenius Kabi SwissBioSim GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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20206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Eysins
Full-timeOn-siteSenior
Nejo AI Summary
Leading medical device development programs for biosimilars, defining device profiles and managing validation. 10+ years in FDA-regulated medical device development required. Central interface role across biosimilars project teams.
Requirements
- Bachelor’s degree or equivalent in Product design, Mechanical, Process, Materials Science or Electronic Engineering
- 5+ years of experience in project management
- 10+ years of experience in device development with understanding of device safety and regulatory requirements
- Deep technical understanding of device design, validation, verification and their link to drug development activities
- Experience in FDA regulated medical devices and combination drug device products
- Track record of resolving issues in a matrix organization
- Strong interpersonal and relationship building skills
- Solid organizational skills including attention to detail and multi-tasking skills
- Effective verbal and written communication
- Fluency in English; additional languages (German or French) are an asset
Tasks
- Lead cross-functional exercises to define targeted device profiles
- Develop project plans and budgets with internal and external teams
- Deliver quality products and processes with proper validation and regulatory documentation
- Report and control device development timelines, budgets, and risks
- Act as the main interface between biosimilars project teams and subteams
- Provide technical and business inputs to projects
- Analyze risks and suggest mitigation plans
- Oversee device development, manufacturing, validation, and regulatory activities
- Proactively identify risk areas and alert stakeholders
- Report and escalate potential issues to management
- Identify new device opportunities
- Lead innovation and continuous improvement projects
Work Experience
- 10 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
- French – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 206030 Fresenius Kabi SwissBioSim GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
206030 Fresenius Kabi SwissBioSim GmbH
Industry
Pharmaceuticals
Not a perfect match?
- SUSONITY
Vice President, Global Program Head Healthcare(m/w/x)
Full-timeOn-siteSeniorEysins - Fresenius Kabi SwissBioSim GmbH
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Business Development Director - injection device development(m/w/x)
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