QARA Manager

About the job

Location: White City as a base for operations with hybrid working and travelling when appropriate

Job Summary

Imperial College is co-locating at the Michael Uren Hub in White City major medical technology research translation initiatives from across the institution. The QARA Manager role is a key role as part of the Wellcome Trust Funded MedTech ONE initiative. 

The MedTech Accelerator, part of the MedTechONE programme, is a new initiative whose mission is to accelerate medical technologies research and development at imperial “from bench to bedside”. One of the support tools offered to MedTech entrepreneurs in Imperial College is an ISO13485 Quality Management System for the Design and Development of medical devices. The QARA Manager will be responsible for maintaining and improving the QMS, overseeing its use across MedTech projects, for providing initial regulatory guidance to projects, and for interfacing with a team of regulatory experts. 

Duties and responsibilities

An experienced QA manager with regulatory expertise in the MedTech sector you will manage Imperial College ISO13485 Quality Management System (QMS), for Design and Development of Medical devices, overseeing all quality processes including the internal audit process. You will assess the QMS readiness of selected MedTech projects, and the QMS requirements for those projects. 

 You will be responsible for maintaining and improving the QMS to ensure it can be used efficiently across a varied portfolio of MedTech projects, and for establishing areas of collaborations with other Medtech groups across College. 

An enthusiastic individual with ISO 13485 Quality System Management Experience, your will promote quality processes amongst projects having entered the Accelerator and /or QMS, and you will provide quality and initial regulatory guidance to researchers and PIs. You will work closely with the Translation Project Managers to ensure the required design and development documentation is delivered for selected projects, in line with applicable regulatory requirements and quality processes, reviewing and approving those documents as required. You will also be responsible for delivering QMS training where required.

You will act as the main point of contact for a team of regulatory experts, who will provide more in-depth support to selected projects. You will oversee the contractual set up and support the delivery of regulatory outputs at point of need for Accelerator projects. 

You will work within a dynamic team of technology transfer individuals with the MedTech community at Imperial College, and in close collaboration with colleagues in the Technology Transfer Office (Industrial Partnerships and Commercialisation team) and wider Enterprise team, supporting the transition of MedTech projects into the next phase of their translation journey.

A key member of the two MedTech programmes, you will be expected to contribute to the Accelerator model and to its sustainability, liaising with MedTech and other accelerator programmes’ operational colleagues, in the Enterprise division and in other departments, and advising the Head of MedTech Accelerator on required changes and improvements to the Quality Management System and related processes. You will be involved in the achievement of the Programmes KPIs and in the drawing together of regular and funding body reports.

This is an exciting and dynamic role, that will provide the recipient with an opportunity to be involved in the delivery of highly innovative MedTech projects, with interactions across the MedTech translation ecosystem at Imperial College. 

Essential requirements

• Experience of QMS management for medical device design and development (ISO 13485)
• Experience working closely with medical device design and development teams, ideally in one of multiple of the following sectors: cardiovascular, diagnostics, rehabilitation technologies, prosthetics/orthotics, orthopaedics, Global health/Appropriate Technologies/Frugal innovation.
• Good Knowledge and experience working within regulatory requirements applicable to medical devices, in the UK, US, EU and in ideally in some LMIC countries.
• Experience working within an ISO13485 quality management system for complex medical devices, including experience with risk management to ISO14971.
• Experience of working in the area of innovation/Research and Development in MedTech at a level suitable to facilitate credibility and positive relations with staff, students, and external partners.
• Knowledge and experience of implementation of ISO 14971 and one or more of IEC 62366-1, IEC 62304 and IEC 60601 parts
• Previous experience and understanding of issues relating to research translation

You will also have:

• Effective communication skills, written and verbal, to ensure clear and effective contact for a contemporary student and alumni audience, academic and industry partners
• The ability to lead on QMS ISO 13485 internal audits, scope changes and improvement
• Strong attention to detail
• A Proactive problem-solving approach
• A good understanding of MedTech industry and key barriers to translation