AX 5093 Quality and Regulatory Manager

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Category: QA and Compliance, Regulatory Affairs Location: West Midlands, UK Job Reference: AX 5093 Job Type: Permanent Package details: Competitive

 JOB SUMMARY:

 The Quality Manager position is new to this company and therefore you will not only be bringing your expertise to the company, but you will be an influential member of the management team from the outset.

 BACKGROUND:

 Initially this role will focus on the Quality side, however there is an aim for the individual to develop and gain Regulatory experience in the post. Full training and mentoring from the Director will be provided.

 Our Client is a highly regarded and extremely professional, leading designer and manufacturer of X-Ray therapy systems. With Head Offices based in Surrey and manufacturing in the West Midlands travel between the sites will be required.

 PRIMARY DUTIES:

 • Lead on the Quality Management System across the multiple Company sites, UK and USA.

 • Liaison with The Notified Body, including preparation for surveillance visits for CE recertification and Health Canada inspections.

 • Corresponding with, and hosting FDA inspections visits as required.

 • Implementing and documentation of GMP as required by FDA purposes.

 • Identifying any discrepancies in the QMS, product or project compliance and addressing them through appropriate channels and support the implementation of corrective actions

 • Responsible for the implementation and monitoring of the CAPA system across multiple sites.

 • Ensuring all research and development projects have the correct understanding and knowledge of the quality requirements necessary to deliver a compliant Design History File and Technical File.

 • Lead the Risk Management activities within the organisation, and deliver training to all relevant staff on risk management methods as applied by ISO 14971.

 • Management and review of the change control processes within the organisation.

 • Plan and conduct third party audits as required.

 QUALIFICATIONS / EXPERIENCE REQUIRED:

 Previous experience working as a QA / RA Manager.

 Good working knowledge of ISO 14971 and ISO 13485

 KEYWORDS:

 QA and Regulatory Manager / QA Manager / Regulatory Manager / West Midlands / Birmingham QA MANAGER / QA Officer / jobs / roles / vacancies

 TO APPLY:

 For a confidential discussion please telephone Paul Foster at AXESS Limited on 020 8560 2300 or, click on “apply now” below, to submit your details

 Only candidates with EU work authorisation will be considered.

 ABOUT AXESS:

 AXESS has been operating since 1990

 We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

 We match professional candidates to the best permanent, contract and interim roles in the market

 Visit us at www.axess.co.uk