01 ott
|
Chiesi
|
Emilia-Romagna
01 ott
Chiesi
Emilia-Romagna
Overview
In this role, you will lead the Device Product Development department to advance Medical Devices and device constituents in drug-device combos, ensuring feasible design, development, manufacturing and testing within quality and regulatory standards.
You will shape strategies from prototyping to product launch, drive innovative device technologies, and manage partnerships with vendors and manufacturing partners.
You will influence the project portfolio, resources, and compliance, while developing a high-performance, cross-functional team in a global R&D; context.
This is a chance to impact how device solutions scale within a patient-focused biopharma environment.
Retribuzione / Benefits
pension
private medical insurance
wellbeing programme
flexible benefits programme
annual premio scheme
relocation support
Responsabilità
Lead and develop the Device Product Development team, ensuring alignment with quality, cGMP, HSE and regulations
Identify optimal design, development and manufacturing strategies from prototyping to launch
Foster innovative device products and testing technologies aligned with company strategy
Participate in due diligences for in-licensing opportunities
Support IP strategy and patent development
Manage strategic vendor relationships (design agencies, CMOs, test labs, consultants)
Ensure successful transfer of device products and specs to Manufacturing or CMOs
Prepare and revise SOPs and processes
Oversee staff development, capability building and resource allocation
Act as centre of excellence for medical devices and combination products balancing internal capacity and outsourcing
Contribute to device project portfolio, resources (CAPEX, OPEX, FTE) and management communications
Ensure safety and environmental compliance
Review and approve Design Controls documentation
Provide expertise in medical device quality, risk management, manufacturing and regulatory frameworks (ISO *****, ISO *****, cGMP)
Requisiti fondamentali
Substantial leadership experience in drug-device combination product development
Experience in managing, coaching and developing teams
Credibility from progressive leadership roles in comparable settings
Proven ability to lead multidisciplinary organizations through growth and transformation
Accountability for strategic R&D; activities from concept to commercialization
Strong scientific and engineering foundation with hands-on industrial experience
Ability to operate at the intersection of innovation, quality, regulatory requirements and business objectives
Strong interpersonal awareness and trust-building
Effective communication and collaboration across diverse teams
Fluent in written and spoken English
leadership
stakeholder management
collaboration
medical device quality (ISO *****)
risk management (ISO *****)
cGMP
📌 Head Of Device Product Development (Emilia-Romagna)
🏢 Chiesi
📍 Emilia-Romagna