Human Factors Lead
CK Group are recruiting for a Human Factors Lead to join a Device Operations and Usability Team of a leading biopharmaceutical organisation at their research and development facilities located in Slough on an initial one year contract.
The Company: Our client is a global biopharmaceutical company whose medicine treats thousands of patients around the world who live with severe diseases.
Location: This role is located on a well-established biopharma R&D facility based in Slough. Thereare good transport links whether you drive or even use public transport. Slough is a great place to live and work and is easily commutable from Reading, Oxford and London.
Human Factors Lead Role: The Human Factors Lead will be responsible for:• 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 packagingand labeling content to support marketed medical devices and drug product programs.
Your Background: To be considered for this Human Factors Lead opportunity you will have the following qualifications, skills and experience:
- 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 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 labelling.
Apply: For more information or to apply for this Human Factors Lead position, please contact Graeme Pallas at CK Science on 0191 384 8906 or email email@example.com, quoting job reference 49040.
It is essential that applicants hold entitlement to work in the UK.