Beschreibung
Human Factors Lead - Greater LondonTo strengthen the Device Operations and Usability a talented individual is needed to fill the position of: Human Factors Lead.
As the Human Factors Lead you will be focused on the human factors activities for clients drug delivery technologies and other medical devices for client 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 labelling content to support marketed medical devices and drug product programs.
- Supporting regulatory/technical aspects of packaging and labelling requirements and specifications.
- Ensuring the appropriate translation of packaging and labelling to support the above activities. This includes physical packaging and labelling as well as digital items.
- Coordinating activities with artwork providers/suppliers, the management of artwork versions within the client systems and visual identity developed by secondary packaging.
- Providing a technical input to Regulatory Affairs labelling activities.
- Operational support for planning, execution, and reporting of Shipping Validation studies to industry and international regulatory agency standards and expectations.
Requirements:
- 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.
- Fluent English
Additional:
- Open to applicants for relocation to the UK.
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.