27 ott - Parma
Chiesi Group
Who we are looking for This 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 CMO Support 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 *****, ISO *****, 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 strategic perspective that comes from many years of progressively broader leadership responsibilities in comparable roles.
Experience in successfully leading multidisciplinary organizations through periods of growth, transformation, and delivery, while developing both individual contributors and teams Can demonstrate sustained accountability for strategic R