RA ASSOCIATE - MEDICAL DEVICES - OXFORDSHIRE - 24-30k

RA ASSOCIATE - MEDICAL DEVICES - OXFORDSHIRE - 24-30k Type: Permanent Reports to: RA Manager Salary:Negotiable Beneftis: Yes Reason: Growth and Investment. Purpose: Provide Regulatory and Quality Assurance support to the business. To operate as a member of the RA team with a mandate to promote a regulatory sound business practice and support the continuous improvement ethic throughout the organisation. Responsibilities: Reporting duties to RA ManagerDeputised responsibilities for RA Manager in their absence.Identify and implement continuous process improvement projects, methodologies and tools to effect efficiency change and associated cost reductions / lean.Ensure compliance to all processes related to the requirements of Regulatory Affairs Dept.As voice of the Customer; ensure the promotion of awareness of customer requirements throughout the organisation in adherence with the Quality Policy. Regulatory Compliance including:Maintenance and implementation of policies and procedures. Tracking regulatory changes (standards / directives).Contact as appropriate with regulatory authorities. Operational Regulatory Affairs including: Coordinate and manage regulatory projects as required.Review change documentation for regulatory impacts.Review and approve labelling, marketing literature and claims substantiation compliance.Working closely with the NPI / R&D team, to lead regulatory input in assigned R&D projects and pre-launch reviews (project management and member of teams)Preparation and maintenance of Technical Files & associated documentation, (e.g. 510(k)s and notes to file.) Complaints, Vigilance and Post Market Surveillance (PMS) including: Coordinate MDR and vigilance reporting. Coordinate Product field corrective actions and product risk management processes. Coordinate the Post Market Surveillance ProcessSupport and coordinate with the RA manager the risk evaluation program and Field correction process Quality Management Systems To participate at a department level the operation of the Quality Management System as defined in Standard Operating Procedures and the associated Departmental Procedures, Work Instructions & Regulatory documents.Non-conformity/CAPA System Raise non-conformities as requiredWork with QA & RA teams to review the status of CAPAs Education: Degree educated or equivalentScientific or Engineering background preferable Minimum 3 years experience in Medical Device Regulatory Affairs / Quality AssurancePrevious experience of involvement in key projectsEssential knowledge of USA FDA QMS, ISO 9001, 13485, Medical Devices Directive, application to Post Market Vigilance (Product Complaints and Recalls) and associated MedDev guidelines.Experience of company representation at country level meetingsExperience in vigilance reporting & communications with regulatory bodies and authoritiesInternal auditor trainedManufacturing experience preferred but not essentialFluent in English, another European language would be an advantage QA / QUALITY ASSURANCE / 13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / ENGINEERING / ASSESSOR / CERTIFICATION / VASCULAR / SOFTWARE / WOUNDCARE / WOUND CARE / QUALITY MANAGEMENT / QUALITY SYSTEMS / PROCESS IMPROVEMENT / PRODUCTION /HEALTHCARE / QA ENGINEER / QA ENGINEERING / SOUTH WEST / OXFORD / OXFORDSHIRE / QA ASSOCIATE / SENIOR QA ENGINEER / MEDICAL DEVICES / HEALTCARE / ISO 13485 / ISO 9001 / CAPA / COMPLIANCE / COMPLIANCE ENGINEER / QUALITY ENGINEER / UK / UNITED KINGDOM / WILTSHIRE / SWINDON / BERKSHIRE / READING / ENGLAND / QC / QUALITY CONTROL / DOCUMENTATION / FDA / EUROPEAN / REGULATORY AFFAIRS / REGULATORY SPECIALIST / REGULATORY ENGINEER / RA SPECIALIST / REGULATORY AFFAIRS / VIGILANCE / REGULATORY SUBMISSIONS / ABINGDON / WITNEY / COWLEY / OXFORD / MHRA / QMS / REGULATORY COMPLIANCE / REGULATORY CONFORMANCE / GLOUCESTER / GLOUCESTERSHIRE / OXFORDSHIRE / ABINGDON / OXFORD / LONDON / SWINDON / BANBURY / DIDCOT / BICESTER / WANTAGE / WITNEY / BERKSHIRE / READING / BUCKS / BUCKINGHAMSHIRE / AYLESBURY / WILTSHIRE / SWINDON / BRISTOL / CLINICAL TRIALS / CLINICAL RESEARCH / THERMO FISHER / OWEN MUMFORD / ABBOTT / STRYKER / ST JUDE MEDICAL / GE HEALTHCARE / FRESENIUS / KABI / BAXTER / BBRAUN / PHILIPS / RESPIRONICS / ELEKTA / GSK / GLAXO / PFIZER / 60601 / 60602 / FDA / CFR 21 / RA OFFICER / RA EXECUTIVE / REGULATORY AFFAIRS / SAUFLON / RELOCATE / ENGLAND . SOUTH WEST / UK / UNITED KINGDOM / EUROPE / BIOMET / BIOMED / BIOMEDICAL / NOVARTIS / MEDTRONIC / BIOTRONIC