Quality & Regulatory Manager, £50-60k, Oxford, Medical Devices

Job Reference: #30068 Add to saved jobs

  • Location Oxford, Chipping Norton, Banbury, Newbury, Swindon, Witney, Gloucester, Cirencester, Reading, Aylesbury, High Wycombe
  • Permanent
  • Sector Medical Devices

Job Summary

Would you like to be involved in developing cutting edge technology improving the lives of patients around the globe? I’m currently working exclusively with a start-up company in Oxford who are seeking an experienced QARA Manager who will be responsible for global regulatory affairs and corporate quality assurance activities. In particular this role will focus on country product registrations and compliance, their Quality Management System and GDPR regulations. Quality & Regulatory Manager, £50-60k, Oxford, Medical Devices Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Job Overview

• Ensure that quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, including ISO 13485 and other standards.
• Maintain regulatory compliance for company products, including registrations, listings, license amendments, 510(k) submissions, letters to file, labelling, UDI, and other requirements
• Create and maintain regular lines of communication with all departments to promote quality awareness, regulatory partnership, and harmonisation of quality processes.
• Conduct internal audits and provide guidance regarding best practices and continuous improvement
• Promote audit readiness, prepare quality teams for audits by external bodies and facilitate audits as needed.
• Maintain expert current knowledge of CE Mark, FDA, GDPR, and other applicable foreign country regulations, legislation, best practices, and guidelines related to QA/RA, monitor changes to applicable laws and regulations, identify impact to the business, and in collaboration with other stakeholders, develop response strategies and/or work plans and complete according to deadlines

Skills Required

• A minimum of 3+ years of experience in the development, implementation, and maintenance of a quality management system
• Experience preparing FDA submissions, license applications, registrations and other product approval documentation and demonstrated knowledge of applicable requirements and practices
• Broad knowledge of medical device regulations (e.g. ISO 13485, etc.)
• Project Management experience

Contact Details

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

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Find out more about us at www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/

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