Hybrid Benefit Risk Evaluation Assessor – Decontamination and Infection Control

at Macedonian Human Resources Association

• Job title: Benefit Risk Evaluation Assessor – Decontamination and Infection Control
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, London, United Kingdom

About the role

• Benefit Risk Evaluation Assessor providing regulatory expertise on sterilisation for clinical investigations at MHRA. Collaborating across teams for effective management of safety signals.

Responsibilities

• Actively participate in meetings and work programmes to assess and investigate safety signals involving sterilisation; effective management of safety issues ensuring relevant assessors are kept up-to-date and quality of work is maintained.
• Provide specialist technical advice and support on sterilisation to other colleagues and senior officials to meet divisional business needs and targets.
• Undertake technical reviews of sterilisation issues as required on new and emerging safety signals and/or new and emerging data/evidence and make recommendations for actions to protect patients.
• Lead on the assessment of sterilisation for clinical investigations and where appropriate, the development of guidance.

Requirements

• Degree or equivalent qualification in life sciences, health care or engineering (such as medical engineering, toxicology, material science, or healthcare qualification); and previous relevant experience gained in healthcare, medical device manufacturing, regulatory environment, or health data science.
• Knowledge or practical experience of medical devices
• Experience of critically analysing complex clinical/scientific/technical information from a number of sources under pressure and make appropriate recommendations or decisions to protect patient safety/public health even when the evidence is not clear. Implement appropriate actions to mitigate risk
• Evidence of writing well-structured, concise, reports to support decision making and provide information to stakeholders.
• Awareness of the regulatory frameworks

Benefits

• Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.
• implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business.
• Some roles will need to be on site more regularly.
• Commitment to continuous development in the area of sterilisation