Medical Devices Regulatory and Quality Consultant

UK wide

Salary up to £45,000 DOE

High Edge Consulting is a successful and growing medical devices consultancy which provides practical solutions to medical device manufacturers throughout the UK and beyond. Due to continued expansion, an opportunity has arisen for an additional Medical Devices Consultant to join the team.

As a Medical Devices Consultant you will be responsible for working with new and established customers, ensuring their compliance with worldwide regulatory affairs and quality systems.

Your focus will be on assisting medical device manufacturers to gain and maintain their quality and regulatory certification, by either providing knowledge, or completing the whole process. This will involve working at client sites throughout the UK for the majority of your time and typically one or two days a week, working at home.

Typically, the role will involve:

• Writing quality systems and classification of devices
• Authoring technical files and design dossiers
• Regulatory submissions
• Establishing CAPA systems
• CAPA resolution
• Performing client internal and vendor audits as a lead auditor
• Liaison with clients notified bodies
• Providing clients with advice and interpretation of the various medical device regulations
• Delivering training courses as well as advice and consultancy on any aspect of ISO 13485, CMDCAS, 21 CFR 820, the Medical Devices Directives

To be considered for this position, you must have:

• A practical and working knowledge of ISO 13485 and the Medical Device Directive 93/42/EEC
• Experience in a customer-facing or consultancy role
• A life sciences degree or extensive practical experience in the medical device industry

Knowledge of the Health Canada and FDA regulations would be beneficial to your application, as would a specialism in a related field, such as biological evaluation, medicinal and borderline products, microbiology, clinical evaluations etc.

Additionally, as the Medical Devices Consultant you should also be able to work on your own initiative or as part of a team and have excellent communication skills. Time management skills are essential as much of the work is deadline based.

A full UK driving licence and your own transport is required as this post involves visits to client premises throughout the UK with frequent overnight stays. Entitlement to work in the EEA is essential.

To apply for the role of Medical Devices Consultant, please simply send your CV and a covering letter to cv@highedge.co.uk, quoting REF HPCI. If you do not receive a response within 7 days, your application will not be progressed any further on this occasion.

No agencies or recruiters.

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