Macedonian Human Resources Association

Communications

• Lead delivery and implementation of effective communications strategies
• Develop and drive forward communications for a high profile programme
• Ensure alignment of communications on the programme with the MHRA’s brand

Communications Specialist – Business Technology Change Programme

• Lead delivery of complex communications strategies across major programmes
• Develop and drive communications for a high profile programme
• Lead communications for major business and digital transformation programme
• Developing and delivering integrated communications plans

Communications Specialist – Strategic Communications

• Lead delivery and implementation of effective communications strategies
• Develop and drive forward communications for a high profile programme
• Ensure alignment of communications with MHRA’s brand and strategic priorities
• Creating high-quality content including messaging and engagement materials

Communications Specialist – Improving Patient Information

General

• Manage the Control Testing Quality Management System (QMS)
• Carry out audits for compliance
• Develop and deliver ISO 17025 QMS training programme
• Provide advice, support, and guidance to Scientists

Quality Lead

Compliance

• Support the continued development and implementation of the future regulatory framework for medical devices
• Lead on discrete areas and work in collaboration with colleagues within Innovative Devices and across the Agency
• Liaise with senior external stakeholders, both in the UK and internationally
• Provide expert regulatory advice to medical device and IVD device manufacturers

Diagnostic Regulatory Specialist

Advisor

• Leading and managing a range of independent advisory committees
• Overseeing the scheduling, preparation, and support of Committees, Advisory Groups, and Working Groups
• Liaising with internal and external stakeholders to ensure meetings are conducted efficiently

Committee Advisor

• Assess the accuracy of documents and data held on internal databases to support applications following initial assessment.
• Assess some variations and abridged simple applications.
• Communicate with and provide advice to internal and external stakeholders, as required.
• Perform compliance assessments (checking of product information on MHRA systems) for new marketing authorisation applications.
• Assessment of Regulation 56 (formerly Article 10c) marketing authorisation applications.
• Assessment of variations subsequent to the grant of a marketing authorisation.
• Work collaboratively to drive continuous improvement within the group.

Scientific and Procedure Advisor

Full-stack Engineer

• Support the development and implementation of the DMHT AI regulatory sandbox
• Assist senior colleagues in various compliance activities
• Engage with internal and external stakeholders to ensure access to safe medical devices
• Collaborate with the safety and surveillance team for compliance activity on digital mental health technologies

Technical Lead – Digital Mental Health

Assessor

• Assess labelling and patient information leaflet applications
• Complete strategic targeted reviews of patient information and suggest improvements to pharmaceutical companies
• Manage and resolve complaints on patient information material from health professionals and the public
• Assist in implementing the Agency initiatives to review labelling for products possibly contributing to medication errors

Senior Scientific Assessor

• Assess the clinical and regulatory aspects of marketing authorisation applications
• Share Knowledge and Development of Self and Colleagues
• Contribute to Policy and Procedures
• Communicate with internal and external stakeholders