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Human Factors Lead

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Research & Early Development
Job ID:  68276

Human Factors Lead

 

To strengthen our Device Operations and Usability, based in our UK head office in Slough, UK we are looking for a talented individual to fill the position of: Human Factors Lead.  
 

As the Human Factors Lead you will be focused on the human factors activities for UCB’s drug delivery technologies and other medical devices for UCB’s chemical and biological medicines including their packaging and labelling needs.
 

You like to work in an environment where you can:

  • Make a difference for people living with severe disease
  • Work closely in partnership with global cross-functional and matrix teams
  • Proactively motivate and anticipate challenges in teams and projects
  • Manage external relationships

 

You will contribute by:

  • 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.
  • Generating 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 to support marketed medical devices and drug product programs.
  • Supporting regulatory/technical aspects of packaging and labeling requirements and specifications.
  • Ensuring the appropriate translation of packaging and labeling to support the above activities. This includes physical packaging and labeling as well as digital items.
  • Coordinating activities with artwork providers/suppliers, the management of artwork versions within UCB systems and visual identity developed by secondary packaging.
  • Providing a technical input to Regulatory Affairs labeling activities.  
  • Operational support for planning, execution, and reporting of Shipping Validation studies to industry and international regulatory agency standards and expectations.

 

Interested? For this position you’ll need the following education, experience and skills:

  • Proven track record in project management and working in cross-functional teams.
  • Pharmaceutical business experience and a familiarity with competitive landscape of devices and pharmaceuticals, drug development process, health economics and health outcomes.  
  • 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. 

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

Apply now »