Human Factors Lead

08 Oct 2020
04 Nov 2020
Contract Type
Full Time
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.

This role is located on a well-established biopharma R&D facility based in Slough. There are 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 packaging and 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.

For more information or to apply for this Human Factors Lead position, please contact Graeme Pallas at CK Science on (phone number removed) or email (url removed), quoting job reference 49040.

It is essential that applicants hold entitlement to work in the UK