More jobs:
Job Description & How to Apply Below
Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).Who
we are looking forThis is what you will do Reporting to the Sr. Director Device Development, the Head of Device Product Development is responsible for managing and overseeing Device Product Development department staff and activities, ensuring feasibility of design, development, manufacturing and testing of Medical Devices and Device Constituent Part of Drug Device combinations products in development and promoting cutting edge approaches and device solutions for device product development.
You will be responsible for Support and oversee the department staff and ensure they work in accordance with company quality, device related cGMP, HSE requirements and regulations
Support the department in the identification of the best design, development and manufacturing strategies from prototyping to product launch
Ensure the identification and development of innovative device products, manufacturing and testing technologies suitable to support Chiesi’s strategy
Participate in Due Diligences for in-licensing opportunities
Support the definition of IP strategies and patents
Scout, identify and manage as per applicable policies the strategic vendors for device related matters including design agencies, CMOs, test labs, consultants, etc Ensure the successful transfer of the device product and relevant manufacturing and testing specifications to Manufacturing or relevant CMOSupport the preparation and revision of relevant SOPs and processes
Identify, manage and develop the staff of the Device Product Development Department, ensuring that their technical skills and competences are aligned with the needs of the projects
Assure the people training, the development of competences and the appropriate allocation of resources and skills to relevant activities, are in compliance with company procedures and project needs
Ensure the department acts as a centre of excellence for medical devices and combination products balancing internal capacity and competences with outsourcing
Contribute to the definition of the device projects portfolio and the required resources (CAPEX, OPEX, FTE) including the proposal communication to the management
Responsible for department adherence to safety and environmental rules and regulations
Review and approval of Design Controls documentation
Expertise in medical device quality, risk management, manufacturing, and regulatory frameworks, including ISO 13485, ISO 14971, cGMP, and related global regulatory requirements.
You will need to have Substantial leadership experience within the development of drug-device combination product combining deep technical expertise with a strong understanding of regulated innovation environments
Experience in managing, coaching and developing teams
The candidate brings the credibility and…
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×