Reference Number: JO-2008-452962
Human Factors Lead – Medical Devices
Job Type: Permanent
Role: Human Factors Lead Medical Devices
Salary: competitive + benefits
employment: full time, permanent
Regulatory Professionals are collaborating with a multinational biopharmaceutical company which focuses primarily on research and development, specifically involving medications centered on epilepsy, Parkinson’s, and Crohn’s diseases. Our client is seeking a Human Factors Lead to join their vibrant team based in Berkshire who will be focused on the human factors activities for their drug delivery technologies and other medical devices for their chemical and biological medicines including their packaging and labeling needs.
Other duties will include:
Operational planning, execution, and reporting of Human Factors studies to industry and in-ternational 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 collabo-ration 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 collabo-ration 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 specifica-tions, e.g. adhesion testing/requirements, material and printing process requirements, legibil-ity/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 ver-sions within UCB systems and visual identity developed by secondary packaging. This includes appropriate budget management, quotations, and negotiations with suppliers.
Delivery of technical input to Regulatory Affairs labeling activities
Right to work in the UK
Proven track record in project management and working in cross-functional teams
Pharmaceutical business experience and familiarity with competitive landscape of devices and pharmaceuticals, drug development process, health economics and health outcomes
Experience in generating technical documentation
Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Regula-tions) 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 prac-tices and expectations in Human Factors/Usability through appropriate external training cours-es, conferences etc.
If you would like to apply for this position, please contact Amani via firstname.lastname@example.org.
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