16 ott - Bari
Chiesi
OverviewIn this role, you will lead the industrialization, validation and lifecycle management of Device Constituent Parts and device platforms, ensuring scalable, compliant development and technology transfer.
You will drive cross-functional alignment across R&D;, Quality, Regulatory, Manufacturing, and external partners to secure regulatory compliance and business continuity.
You will oversee validation plans, change management and risk assessment to improve device robustness and manufacturing reliability.
This position offers the opportunity to shape end-to-end device lifecycle within a global supply framework and contribute to a sustainable, high-quality product pipeline.
Retribuzione / Benefitsannual premio
comprehensive benefits package
company pension
private medical insurance
relocation support
remote work options
ResponsabilitàLead industrialization and scale-up projects for Device Constituent Parts (DCPs) across development, validation and technology transfer
Provide technical leadership for validation, change management, risk assessment, and industrial development across device platforms
Coordinate cross-functional projects involving R&D;, Quality, Regulatory Affairs, Engineering, Manufacturing Sites, and CMOs
Prepare, execute and review validation plans, protocols, reports, and development studies supporting lifecycle initiatives
Support investigations, root cause analyses and corrective actions to ensure product robustness and business continuity
Assess and implement changes affecting Device Constituent Parts
Collaborate with sites and partners to align on technical strategies, process improvements, scale-up and lifecycle management
Contribute to technical documentation for regulatory submissions and compliance with Medical Device Regulation
Requisiti fondamentali8-10 years in industrialization, validation, and lifecycle management of medical devices and/or drug-device combination products
Strong engineering background with hands-on product development and manufacturing experience
Proven experience leading cross-functional technical projects
Solid understanding of regulated environments, validation practices, change management and Medical Device Regulation requirements
Experience supporting industrialization, scale-up, technology transfer and process improvements across multiple sites and CMOs
Ability to translate technical data into actionable recommendations for multidisciplinary teams
Effective stakeholder management and communication skills
Strong analytical and problem-solving capabilities including investigations and root cause analysis
Ability to balance technical, quality, regulatory, timeline and business considerations in complex projects
Collaborative mindset for matrix organizations and external influence
Expertise in medical device quality, risk management, manufacturing and regulatory frameworks (ISO *****, ISO *****, cGMP)
Fluent in written and spoken English
stakeholder management
communication
problem-solving
medical device quality systems
risk management (ISO *****)
regulatory frameworks (ISO *****, regulatory submissions)
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