Overall Purpose of Job: Provide Regulatory and Quality Assurance support to the business. To operate primarily 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. To deputise for Director QARA.
- Reporting duties to Director QARA
- Deputised responsibilities for QARA Mgt 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 & Quality Management Systems.
- As voice of the Customer; ensure the promotion of awareness of customer requirements throughout the organisation in adherence with the Quality Policy.
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.)
- Coordinate the technical file maintenance plans
- To maintain an awareness of the company's external regulatory contacts and define sources of information appropriate for performing key tasks.
- Maintenance of site establishment registrations and device listings
- Provide documentation for product registrations
- Produce documentation for on-market changes
- Assist in improving the culture of all staff in the regulatory and quality assurance requirements relating to medical devices.
- Help establish standards of service for customers and clients.
- Plan workflow through the department to ensure timely delivery of all projects.
- Responds and resolves general regulatory issues
- Complete training in accordance with company procedures
- To portray at all times a professional and ethical image
- Promote quality within the organisation
- Assist in developing and conducting internal training programmes to promote the awareness of the importance of regulatory issues to other departments, as appropriate.
- General Management Requests
- Complete tasks as assigned by Manager in a timely manner.
- General support and assistance in technical or other matters of expertise as and when required.
- Health and Safety
- To ensure compliance with the Company Health and Safety Policy and any further policies, actions or requirements arising.
Qualifications / education required:
- Degree educated or equivalent
- Scientific or Engineering background preferable
QA / QUALITY ASSURANCE / 13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / RA / 60601 / 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 / 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
- Quality Assurance
- Regulatory Affairs
- Scientific Background