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Medical Device Directive Reviewer - Surrey
£45,000 -£55,000 plus benefits
A fantastic career opportunity has arisen for Medical Devices Reviewer to come a join a highly established, worldwide organisation. This fantastic opportunity is on the lookout for individual to come a join their success as they regulate high class Medical Devices in the world providing high quality and safety solutions. This reputable organisation has over 7000 employees and serves customers over 80 different countries.
As a Medical Device Reviewer, you will be a part of the companies notified body team. You will be working with limited supervision, performing key responsibilities; to assist in the management the global procedural documents, you will independently work on technical file/design dossiers assessments and QMS Audits under ISO 13845 for active and non-active Medical Devices. The role also includes assisting and providing strong guidance and support to customers when requires, partake in the development of the company training materials and delivery of the same internal and external company assessors. You will also take responsibly in providing independent reviews of the non-active Medical Devices that include technical design Dossiers assessments outputs and QMS outputs.
You must be educated to degree level, you will need to clearly demonstrate good working knowledge of ISO 13485 and ISO 14971 or ISO 60601is an advantage, substantial amount of auditing experience also in meeting regulatory requirements (CE Marking, FDA). They are also looking for someone who has good technical knowledge and experience in MDD Audits, Experience in own Brand Labelling, substantial experience with MDD 93/42/ECC. Furthermore, you will possess excellent communication and interpersonal skills have good leadership skills.
If you want to be a part of this exciting opportunity who offers a competitive salary, excellent benefits package, including company pension, Life Assurance, and Healthcare, please contact Ekta Multani, Recruitment Consultant at Paramount Recruitment 0121 616 3474.
Keywords: Medical Device, Auditor, Quality Assurance, Quality Engineer, Medical Devices, Medical Electronics, ISO 13485, Quality Systems, ISO60601, 10993, MEDDEVS, Surrey, CAPA, Medical Device Directive, QMS, Metrology, Audit Design, 21 CFR part 820, Quality Control, Management, Six Sigma, , Quality Engineering Manager, ISO 14971, MDD, CMDCAS, Regulatory Affairs, MDD 93/42/ECC
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