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

Posted 29 January by Bosch Global Associates Ltd

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 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

Education:

  • 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

Required skills

  • Auditing
  • Medical Devices
  • Quality Assurance
  • Regulatory Affairs
  • ISO13485

Reference: 31493483

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