RA ASSOCIATE - MEDICAL DEVICES - OXFORDSHIRE - 24-30k
Reports to: RA Manager
Reason: Growth and Investment.
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.
- Reporting duties to RA Manager
- Deputised 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 Process
- Support 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 required
- Work with QA & RA teams to review the status of CAPAs
- Degree educated or equivalent
- Scientific or Engineering background preferable
- Minimum 3 years experience in Medical Device Regulatory Affairs / Quality Assurance
- Previous experience of involvement in key projects
- Essential 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 meetings
- Experience in vigilance reporting & communications with regulatory bodies and authorities
- Internal auditor trained
- Manufacturing experience preferred but not essential
- Fluent 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
- Medical Devices
- Quality Assurance
- Regulatory Affairs