Head of Device Product Development

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Department: GTD Global Technical Development

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma or Chiesi Affiliates in , IT

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. 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 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 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 ma