Benefit Risk Evaluation Assessor - Software

www.findapprenticeship.service.gov.uk - Jobboard; London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A regulatory agency in London is seeking a Benefit Risk Evaluation Assessor specializing in software as a medical device. In this role, you will assess safety signals, manage risk evaluations, and lead projects while mentoring junior staff. Candidates should have experience in software safety assessments and a strong understanding of regulatory changes. This position offers an opportunity to impact patient safety significantly.

Qualifications

• Experience in assessing safety signals for software as medical devices.
• Ability to provide specialist technical advice on medical software.
• Strong management skills in risk/benefit evaluations.

Responsibilities

• Assess safety signals and manage reports for software as medical devices.
• Develop and implement regulatory changes and provide stakeholder guidance.
• Lead projects and mentor junior staff in patient safety goals.

Job description

Benefit Risk Evaluation Assessor - Software

Actively participate in meetings and work programmes to assess safety signals involving software as medical devices; effective management of trending activities and safety signal reports ensuring cases are kept up-to-date and quality of work is maintained. Provide specialist technical advice and support on software as a medical device to other colleagues and senior officials to meet divisional business needs and targets. Undertake technical reviews of software as a medical device as required on new and emerging safety signals and/or new and emerging data/evidence and make recommendations for actions to protect patients. Develop and implement regulatory changes on software as a medical device through legislative reform and clarificatory guidance and provide advice and guidance to stakeholders as this evolves. Effective management of risk / benefit management reports (risk analysis, risk control and risk evaluation) to ensure robust and timely regulatory decisions for software as a medical device. Ensure patient experience informs benefit risk decisions by identifying and providing opportunities for patient involvement in benefit risk evaluations. Process, manage and draft correspondence within own area of business including safety messages and other safety advice documents. Represent Agency at advisory and external meetings, high profile issues and topical issues to provide authoritative up to date advice and regulatory position. Be the lead benefit risk evaluation assessor for safety on Expert Advisory groups and/or short life working groups as appropriate to support effective benefit risk evaluations of potential safety issues. Lead/contribute safety expertise to national and international committees and fora to set and improve standards for medical products. Lead and develop cross portfolio projects identifying and deploying resources and mentoring more junior staff as required to achieve agency patient safety goals. Be proactive in contributing to developments in issues relating to software as a medical device, its use and regulation.