Human Factors Lead

**Make your mark for patients.**

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our **UK Devices Team**, based **in Slough UK**, we are looking for a talented individual to fill the position of:
**Human Factors Lead**

**The** **Human Factors Lead** **is a Global position that will focuse on the human factor activities for UCB’s drug delivery technologies and other medical devices for UCB’s chemical and biological medicines including their packaging and labeling needs. This will be performed in collaboration with the cross functional technical program teams that ensure the design, development and life cycle management of medical device programs for patients.You will work across the portfolio of Device packaging and wearable technologies, leading human factor activities and partnering with external and internal stakeholders.**

**You like to work in an** **environment **where you can contribute to the following**:

- Operational planning, execution, and reporting of Human Factors studies to industry and international regulatory agency standards and expectations
- Preparing and communicating material for submission to regulatory authorities, principally in the context of human factors studies
- Generation of supportive materials, including provisional artwork and physical documents to support the conduct of Human Factors usability studies
- Project management, creation and maintenance of packaging and labeling content in collaboration with secondary packaging defining the visual identity (design, text, technical elements) to support marketed medical devices (e.g. user manual, label text, carton text, instructions for use) and drug product programs (e.g. pharmacy manual)
- Project management, creation and maintenance of packaging and labeling content in collaboration with secondary packaging defining the visual identity (design, text, technical elements) to support medical devices and drug product programs in development (as above)
- Support regulatory/technical aspects of packaging and labeling requirements and specifications, e.g. adhesion testing/requirements, material and printing process requirements, legibility/readability testing, cleaning testing
- Ensuring the appropriate translation of packaging and labeling to support the above activities. This includes physical packaging and labeling (e.g. instructions for use) as well as digital items (e.g. graphical user interface)
- Coordination of activities with artwork providers/suppliers, the management of artwork versions within UCB systems and visual identity developed by secondary packaging. This includes appropriate budget management, quotations, and negotiations with suppliers.
- Use of appropriate systems (Global Master Packaging System (GMPS)) to manage packaging and labeling materials
- Provision of technical input to Regulatory Affairs labeling activities

**Your experience and requirements**:

- Proven track record of project management and abilities to work within a complex matric environment
- Experience within medical devices with familiarity of competitive landscapes and drug development processes
- Experience in generating technical documentation
- Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Regulations) and evolving regulatory expectations in the field of medical devices and mobile health, including human factors engineering
- High level of expertise in Human Factors/Usability engineering per FDA/IEC 62366 and AAMI standards with an expectation to continual maintenance and awareness of current best practices and expectations in Human Factors/Usability through appropriate external training courses, conferences etc.
- Experience in medical device risk management activities as relates to medical device packaging and labeling
- Experience in managing and negotiating project budgets and quotes
- Experience in graphical design and related software tools (Adobe Illustrator, or comparable)

**About us.**

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ens