Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): On Application
Quality Assurance & Regulatory Affairs Specialist - Cheshire - Medical Devices Our client is the manufacturer of a broad portfolio of Medical Devices which are available globally. At present they are seeking an ambitious QA/RA Specialist
Quality Assurance & Regulatory Affairs Specialist - Cheshire - Medical Devices
Our client is the manufacturer of a broad portfolio of Medical Devices which are available globally. At present they are seeking an ambitious QA/RA Specialist with a background working in medical devices either in a QA or an RA role.
Cheshire - This position would suit someone residing in Cheshire or the surrounding counties, candidates willing to relocate will also be considered
Salary and benefits:
Negotiable up to £26,000 per annum plus benefits
*To be involved in audits conducted by notified bodies and competent authorities as required by the company and in the absence of the RA & QA Manager.
*Ensure that all Quality Agreements with suppliers to the business are fully up to date, signed and agreed by suppliers.
*To ensure that all of the company's product specification are updated in timely manner and comply with the design specifications agreed by the supplier.
*To provide general support to the Quality & Regulatory Affairs Manager, including completing any reasonable ad-hoc tasks requested by management.
*Monitor and track various QMS oriented systems.
*Responsible for maintaining and updating the QMS from time to time as required. Create new documents and update existing documents as per the internal document management system.
*To conduct regular and documented reviews of outstanding actions and gaps which require to be fully addressed.
*Review and update Sterilisation reports from various suppliers
*Where required train and educate the team or company staff on various QA & RA processes and requirements.
*Responsible for the review of current legislation within Europe and on a global basis for changes to legislation affecting Technical File information and submission requirements.
*Compile technical file information as required by the business to be able to comply with the MDD specifically review and update the validation documents from various suppliers.
*Apply the STED format for Technical File compilation and ensure that all materials and information are accurate as required by the requirements of MDD.
*To produce information and data on a monthly basis for management reports relating to Technical File status, updates and gaps as required by the QA and RA Manager.
*To advise the RA & QA Manager of changes in legislation directly affecting the status of Technical Files.
*Management and control of the artwork and packing approval process ensuring that only the latest version of artwork is available.
*Liaison with notified bodies and competent authorities with regard to Technical File details and requirements.
*Experience of working within the medical devices industry (essential)
*Experience of working with contract manufacturers and suppliers (essential)
*Experience of ISO 13485 and MDD experience (essential)
*Experience of keeping detailed records (essential)
*Experience in dealing with queries and investigation (essential)
*Experience with Sterilisation validation ( EtO, Gama) (desirable)
*Experience in dealing with notified bodies and competent authorities (desirable)
*Experience of Internal Audits (desirable)
This is a rare opportunity for a candidate with a baseline of experience within QA/RA related to the medical devices sector to step-up into a specialist role and progress their career.
Clinical Professionals is Europe's leading provider of Life Sciences staff with a unique and dedicated medical device team with a deep rooted knowledge of Medical Technology and staffing. Our Medical Devices Team is focused on finding Clinical Research, Regulatory and Quality positions at all levels.
Regulatory affairs, quality assurance, medical devices, MDD, specialist, Cheshire, Manchester
3rd floor 33 Blagrave Street Reading
|Tel:||+44 (0)118 9522 797|
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