I have a brilliant opportunity for a QARA Manager to join a forward-thinking, and established organization based in London.

The ideal candidate will possess a robust background in Quality & Regulatory affairs and excel in a hands-on, entrepreneurial setting. We are seeking a true critical thinker with a pragmatic approach, capable of collaborating across different teams. This individual will play a pivotal role in supporting the company throughout the entire product development and testing lifecycle, ensuring that the organization achieves its Quality and Business Objectives.

This role will offer you

• The ability to implement and shape the quality department, with support and guidance from senior leadership.
• The chance to join an organisation the genuinely cares about its people, with scope to advance and progress your career at any level.
• A creative and flexible working environment.

You will be responsible for

• Lead the creation of online training materials related to the design, development, and quality management of medical devices
• Evaluate and authorize project documentation as needed
• Assist in establishing regulatory pathways in partner Low- and Middle-Income Countries (LMICs) for collaborative projects
• Serve as the primary contact for initial regulatory guidance to Accelerator projects
• Coordinate with external quality/regulatory experts, overseeing contracts related to quality and regulatory tasks
• Complete necessary training as required
• Perform other duties appropriate to the position's grade as directed by the supervisor

You will bring the following

• Minimum educational attainment of a bachelor's degree (or equivalent) in a science or engineering field
• Completed training in ISO 13485 Quality Management System (QMS) implementation or an equivalent program
• Demonstrated experience in overseeing the successful delivery of outcomes, effectively engaging and directing diverse groups of suppliers, colleagues, and collaborators, and providing formal reports on the same
• Familiarity with the UK Medical Device Regulation (MDR), 21CFR820, MDR, and regulatory requirements in the USA (fda).

If you want to be part of an innovative thinking, growing company where you can grow and expand your current knowledge, GET IN TOUCH by emailing me on

matthew.downs@biotalent.com