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Role Filled
QA & RA Specialist
Medical Devices & Equipment
Regulatory & Compliance
Medical Devices
Twickenham
£35,000 - £45,000
Woundcare (NP)
Single Use/Equipment
Role Overview
They are looking for a QA and Regulatory Affairs Specialist to join their dynamic Medical Devices team. The ideal candidate will join a team who are looking to launch innovative technology with both Medical and Engineering applications.
The candidate will play a fundamental role in maintaining continued regulatory compliance with standards and medical device regulations. Training and education will be provided as required to enable the candidate to develop their potential and build on their skillset.
Company Information
QA & RA Specialist
Zenopa is partnering with a growing company who are commercializing cold plasma technology and driving into new markets.
Role Requirements
– QMS management (Quality Manual, policy, Quality objectives, QMS planning, QMS meeting, staff training, Change Plan)
Management, maintenance, and compliance (ISO13485/MDR/UKCA) with Standard Operating Procedures (SOPs), internal policies related to Quality Management System and their training to the relevant individuals.
– Responsible for management and planning of the internal audit programme and conducting internal audits. Supporting external NB audits.
– Post-Market Surveillance activities -Implementation of PMCF plans • PMS data collection, analysis, reporting • Clinical Evaluation Report inputs, review and update
– MDR and UKCA planning and implementation
– Review of Technical Files, Risk Management and GSPR
Person Specifications
– Drive to succeed – The drive and ambition to put energy into achieving results and take action to exceed goals and expectations.
– Flexibility and Resilience – the ambition to achieve results in demanding business environments. Be resilient, adapt and respond positively to a variety of situations and people to meet changing priorities.
– Initiative – The drive to identify or anticipate changes, including an active and creative approach to addressing those opportunities or challenges.
– Attention to Detail – The desire to achieve accuracy, conscientious and have a passion for excellence in all tasks.
– Communication, impact & influence – The ability to convince, persuade, influence or impress others (internally and externally)
towards a point of view, including working collaboratively with others to gain agreement to a course of action, idea or future vision.
Package
Please reach out to matthew@zenopa.com
Locations
Aldershot
Banstead
Camberley
Carshalton
Chertsey
Chessington
Clapham
Ealing
Egham
Epsom
Fulham
Greenford
Guildford
Harrow
Hayes
Kingston-upon-Thames
Leatherhead
Maidenhead
Marlow
Morden
Northolt
Pinner
Putney
Richmond upon Thames
Ruislip
Slough
South West London
Southall
Staines
Sutton
Twickenham
Wandsworth
Wembley
West London
Westminster
Wimbledon
Windsor
Woking
Previous Listing
Date Updated
04 Aug 2023
Job reference
69152
Categories
Full Time
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The Zenopa Salary Guide is based on Zenopa industry experience, it is not specific to this particular job, but it is useful to provide you indicative information and enable you to find jobs when searching salary bands. Individual jobs salary ranges are frequently not released into the public domain, this will be released to you upon application.
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