2217 BD Switzerland Sarl 2217
Business Development Director - injection device development(m/w/x)
Vollzeitnur vor OrtSenior
Eysins
ab CHF 158.600 - 253.775 / Jahr
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
20206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Eysins
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 206030 Fresenius Kabi SwissBioSim GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Vollzeitnur vor OrtSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Director Global Alliance Management(m/w/x)
Vollzeitnur vor OrtSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Vollzeitnur vor OrtSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Manager IV Fluids Global Portfolio(m/w/x)
Vollzeitnur vor OrtSeniorEysins
20206030 Fresenius Kabi SwissBioSim GmbH
Senior Manager Medical Device Program Lead(m/w/x)
Eysins
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 206030 Fresenius Kabi SwissBioSim GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
206030 Fresenius Kabi SwissBioSim GmbH
Branche
Pharmaceuticals
Noch nicht perfekt?
- 2217 BD Switzerland Sarl 2217
Business Development Director - injection device development(m/w/x)
Vollzeitnur vor OrtSeniorEysinsab CHF 158.600 - 253.775 / Jahr - Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Vollzeitnur vor OrtSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Director Global Alliance Management(m/w/x)
Vollzeitnur vor OrtSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs CMC(m/w/x)
Vollzeitnur vor OrtSeniorEysins - Fresenius Kabi SwissBioSim GmbH
Manager IV Fluids Global Portfolio(m/w/x)
Vollzeitnur vor OrtSeniorEysins