Quality Assurance Manager job in London

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This vacancy has now expired. Please see similar roles below...

ProClincial is working with a multiple award-winning healthcare company that is seeking a Quality Assurance Manager to be based in London on a permanent basis. We are looking for an energetic Regulatory Affairs Specialist who will support the company's life cycle management activities.

Job Responsibilities

You will secure the Class I medical device certification for our software as a medical device (SaMD) product
You will build the strategy and drive the internal project to secure Class IIa medical device approval as per the new MDR

Skills and Requirements:

Understanding of the new European Medical Devices Regulation (MDR)
Advanced knowledge of ISO 13485
Direct experience with medical device approvals in European markets, including knowledge of design validation and verification procedures for software as a medical device (SaMD)
Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Experience interfacing with competent authorities regarding audit activities and resolution of observations
Comfortable leading in a high-pressure environment typical of regulatory audits
Ideally experience of ISO 270001
Ideally have experience as an ISO Auditor

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44 203 8261 330 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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