Human Factors Lead

Hobson Prior are looking for a Humans Factors Lead to join a leading pharmaceutical organisation in Slough, where you will join their Device Operations and Usability team. This position will be focused on the human factor's activities for the organisation's drug delivery technologies and other medical devices for chemical and biological medicines including their packaging and labeling needs.

Job Responsibilities:

• Accountable for operational planning, execution, and reporting of Human Factors studies to industry and international regulatory agency standards and expectations.
• Generation of supportive materials, including provisional artwork and physical documents to support the conduct of Human Factors usability studies.
• Preparing and communicating material for submission to regulatory authorities, principally in the context of human factors studies.
• Project management, creation and maintenance of packaging and labeling content in collaboration with secondary packaging defining the visual identity to support marketed medical devices and drug product programs.
• 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.
• You will ensure the appropriate translation of packaging and labeling to support the above activities.
• Coordination of activities with artwork providers/suppliers, the management of artwork versions within the organisation's systems and visual identity developed by secondary packaging.
• Use of appropriate systems (Global Master Packaging System (GMPS)) to manage packaging and labeling materials.
• Provision of 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.

Key Skills:

• Strong attention to detail.
• Program advocacy, negotiation (internal and external) and conflict resolution.
• Written and oral presentation skills.
• Project management skills in planning, tracking, controlling, anticipating.

Requirements:

• Master's Degree.
• 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 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.
• Experience in medical device risk management activities as relates to medical device packaging and labelling.
• Experience in managing and negotiating project budgets and quotes.
• Experience in graphical design and related software tools (Adobe Illustrator, or comparable).
• HS&E processes and procedures.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.