QA/RA Manager - South Wales

Job Reference: #11800 Add to saved jobs

  • Location South Wales, Bristol, Gloucester, Wales, Swansea, Herefordshire.
  • Permanent
  • Sector Medical Devices

Job Summary

My client is a small innovative business based in Cardiff that is now looking for a QA/RA Manager to join their team. The main function will be to ensure that the Company’s products and services comply with relevant regulations, are fit for purpose, meet the performance and specification defined and the expectations of the Company and its customers.

Job Overview

• Lead all communication with regulatory authorities and Notified Bodies
• Maintain a detailed knowledge of the regulatory requirements associated with the markets served and ensure that the Company’s quality system and methods of working are sufficient to comply with those requirements.
• Facilitate/manage all regulatory submissions for market authorisation for MBL products. Ensure pre- and post- commercialisation regulatory compliance for MBL products.
• Participate in all project, departmental and management meetings representing the RAQA function
• Deliver the Internal Audit programme and lead/coordinate MBL activities during External Audits
• Maintain up to date knowledge of domestic and international quality and regulatory standards and requirements and assist relevant functions to define the processes and procedures that Company needs to adopt to achieve its business goals.
• Maintain the quality system documentation processes and procedures adopted by the company
• Prepare quality and regulatory reports, data presentations and other forms of communication of work achieved suitable for internal, regulatory and customer use.
• Monitoring of key performance indicators and trending of data for preventative actions.
• Perform the quality assurance check of manufactured product as part of release product for sale, and ensure released product has appropriate controls on its regional (regulated) availability.
• Perform the role of Management Representative.

Skills Required

• Understands Quality Standards and Regulatory Structures
• Knowledge and experience of IVD’s and/or Medical Devices and regulatory framework
• Extrapolation of data and results to indicate issues, resolutions, activities and checks.
• Can co-ordinate and deliver Quality and Regulatory strategy and plans
• Acts as the quality / compliance role model and coaches MBL team to improve.
• Understands Quality Standards and Regulatory Structures
• Experienced in Quality/Regulatory professional with a minimum of 4 years working in a senior quality / compliance position within the IVD/medical device industry.
• Experience of at least one of the following; microbiology, molecular biology or In Vitro Diagnostics.
• Extrapolation of data and results to indicate issues, resolutions, activities and checks.
• Can co-ordinate and deliver Quality and Regulatory strategy and plans
• Acts as the quality / compliance role model and coaches MBL team to improve.
• Networked and able to extend and impart knowledge within the regulatory and quality framework

Contact Details

Full job description and company details are available upon application, apply below. This position is being dealt with by Joseph Dykes at Meet, please call 0203 178 7488. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.

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