Benefit Risk Evaluation Assessor Decontamination & Infection Control

Job description

Job responsibilities

Reporting to the Biosafety, Nonclinical and Emerging Technologies TAU Head, the assessor will conduct benefit risk evaluations within the therapeutic area and provide input into the development of the Benefit Risk Evaluation Group within Safety and Surveillance.

Sterilisation safety is an essential requirement to the safety of medical devices. The purpose of this role is to work within the specialist area of Biosafety, Non-clinical and Emerging Technologies (TAU2). The role holder will provide support to the sterilisation and infection control team Infection control team working across all aspects of safety both pre-market in the assessing of clinical investigations applications for novel medical devices and post-market activities where issues have been identified following UKCA/CE post market surveillance investigations.

You will be experienced in the rapid review, assimilation, and analysis of complex data as well as proven ability to work effectively with minimal supervision to evaluate and provide insight into complex medical device issues. You will have some understanding of Sterility assurance and methods of sterilisation used commercially and within research institutions.

As a sterilisation and infection control specialist you will become a technical lead for medical devices specialising on sterility assurance aspects. As technical lead you will be responsible for the investigations into contamination issues arising from device related adverse incident and trending activities. You will work with junior and senior colleagues giving advice and recommendations and taking responsibility for ensuring safety issues identified from the device investigation are acted on in a timely manner to the healthcare professions.

You will work across departments to support and implement safety signal detection systems that support incident investigation and risk management.

The Benefit Risk Evaluation Group works in a matrix manner across therapeutic groups and the wider agency as required to ensure patient safety is at the centre of all we do. All benefit risk roles require working flexibly to perform and contribute to benefit risk assessments across all medical products as required. The post holders will be required to be adaptable and to develop knowledge in medical devices regulations and standards relating to sterilisation of medical.

The work will require liaising with stakeholders from healthcare, industry and other key stakeholders.

Person Specification

Qualifications

Essential

• Degree or equivalent qualification in a related discipline (such as decontamination sciences, physical sciences, biological sciences, pharmacy, engineering or a relevant healthcare qualification).

Behaviours

Essential

• Communicating and influencing - Communicate in a straightforward, honest and engaging manner, choosing appropriate styles to maximise understanding and impact. Ensure communication has a clear purpose and takes into account peoples individual needs. Share information as appropriate and check understanding.
• Making Effective Decisions - Display confidence when making difficult decisions, even if they prove to be unpopular. Consult with others to ensure the potential impacts on end users have been considered. Gain a clear understanding of customers needs and expectations. Act to prevent problems and provide solutions.

Experience

Essential

• Proven understanding of risk management principles to reduce harm and promote effective use of medical products. Technical knowledge and/or practical experience of a range of medical devices
• Proven experience of managing complex projects to agreed milestones and managing conflicting priorities
• Proven experience in conducting benefit risk evaluations of medical devices and or medicines is highly advantageous

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Medicines and Healthcare Products Regulatory Agency

Address

Medicine & Healthcare Regulatory Agency

10 South Colonnade

London

E14 4PU

Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency (Opens in a new tab)