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Human Factors Lead

Berkshire SL1 3WE   •  Contract/Temporary, 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.

Location:
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.

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 gpallas@ckscience.co.uk, quoting job reference 49040.

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


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Graeme Pallas
  • Phone: 0191 384 8905
  • Reference: 49040
  • Posted: 8th October 2020
  • Expires: 5th November 2020

CK Group

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