Back to search results

QARA Manager - MedTech

Imperial College London - Department of Bioengineering

Location: London
Salary: £51,115 to £61,549
Hours: Full Time
Contract Type: Fixed-Term/Contract
Placed On: 29th September 2022
Closes: 25th October 2022
Job Ref: ENG2304
 

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

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 joint appointment between two MedTech programmes, the Wellcome Trust Funded MedTech ONE initiative and the NIHR Global Health PrOTeCT programme.

Key duties and responsibilities

An experienced QA manager with regulatory expertise in the MedTech sector you will manage Imperial College ISO13485 certified Quality Management System (QMS), for Design and Development of Medical devices, overseeing all quality processes as well as the certification 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 those being developed as part of the iPrOTeCT programme, and you will provide quality and initial regulatory guidance to researchers and PIs. Based on previous Global Health regulatory experience in Prof Bull’s group, as part of the IPrOTeCT programme, you will establish the required connections and regulatory pathway in partner LMICs. 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.

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
  • Proven experience of securing, or helping others to secure, funding for translational development /innovation

Further Information

This position is full time, fixed term till 30/06/2025.

For Informal enquires email: a.roques@imperial.ac.uk

Any queries regarding the application process contact: Yusra Vallimohamed at Y.vallimohamed@imperial.ac.uk 

Committed to equality and valuing diversity, we are an Athena SWAN Silver Award winner, a Stonewall Diversity Champion, a Disability Confident Employer and work in partnership with GIRES to promote respect for trans people.

Closing date: 25/10/2022

We value your feedback on the quality of our adverts. If you have a comment to make about the overall quality of this advert, or its categorisation then please send us your feedback
Advert information

Type / Role:

Subject Area(s):

Location(s):

Job tools
 

PhD Alert Created

Job Alert Created

Your PhD alert has been successfully created for this search.

Your job alert has been successfully created for this search.

Ok Ok

PhD Alert Created

Job Alert Created

Your PhD alert has been successfully created for this search.

Your job alert has been successfully created for this search.

Manage your job alerts Manage your job alerts

Account Verification Missing

In order to create multiple job alerts, you must first verify your email address to complete your account creation

Request verification email Request verification email

jobs.ac.uk Account Required

In order to create multiple alerts, you must create a jobs.ac.uk jobseeker account

Create Account Create Account

Alert Creation Failed

Unfortunately, your account is currently blocked. Please login to unblock your account.

Email Address Blocked

We received a delivery failure message when attempting to send you an email and therefore your email address has been blocked. You will not receive job alerts until your email address is unblocked. To do so, please choose from one of the two options below.

Max Alerts Reached

A maximum of 5 Job Alerts can be created against your account. Please remove an existing alert in order to create this new Job Alert

Manage your job alerts Manage your job alerts

Creation Failed

Unfortunately, your alert was not created at this time. Please try again.

Ok Ok

Create PhD Alert

Create Job Alert

When you create this PhD alert we will email you a selection of PhDs matching your criteria.When you create this job alert we will email you a selection of jobs matching your criteria. Our Terms and Conditions and Privacy Policy apply to this service. Any personal data you provide in setting up this alert is processed in accordance with our Privacy Notice

Create PhD Alert

Create Job Alert

When you create this PhD alert we will email you a selection of PhDs matching your criteria.When you create this job alert we will email you a selection of jobs matching your criteria. Our Terms and Conditions and Privacy Policy apply to this service. Any personal data you provide in setting up this alert is processed in accordance with our Privacy Notice

 
 
More jobs from Imperial College London

Show all jobs for this employer …

More jobs like this
Join in and follow us

Browser Upgrade Recommended

jobs.ac.uk has been optimised for the latest browsers.

For the best user experience, we recommend viewing jobs.ac.uk on one of the following:

Google Chrome Firefox Microsoft Edge