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Regulatory Affairs Manager - Medical Devices - Scotland
Salary: 45,000 - £50,000
An innovating Medical Devices company are currently seeking a talented Regulatory Affairs professional to come and join a prestigious worldwide organisation. Due to the rapid growth of the company based in Scotland they are looking for Regulatory Affairs Manager to work towards meeting company Regulatory projects.
This world's leading; manufacturing and design Medical devices organisation provide lifesaving products to healthcare companies as well as hospitals worldwide. They have a strong portfolio in meeting the specialised Quality requirements worldwide
They are looking highly motivated and talented Regulatory Affairs Manager to continue the successful of their high prestigious organisations that will hold the following responsibilities:
*Maintain all Technical files and Master files for all classes of Medical Devices
*Liaise with Regulatory Bodies
*Conduct day to day Regulatory activities of the regulatory department.
*Review labelling, packing and marketing literature
*Communicate and manage external partner relationship in regards to Regulatory matters
*Development and maintenance of company Regulatory strategy and systems to ensure appropriate compliance.
*Writing Regulatory documentation for Regulatory submissions for global markets
*Working on Quality Management systems (QMS)
A Successful candidate must have experience working within a regulatory environment; have knowledge of Medical Devices products. Experience in preparing and submitting 510K applications, knowledge of cGMP, FDA & PMA. Show the ability to demonstrate initiative and attention to detail, good organisational skills and the ability to work to deadlines across multiple simultaneous projects.
If successful, you will be rewarded with a completive salary, company pension scheme. If you want to be a part of this exciting opportunity, Please contact Ekta Multani, Medical Devices Recruitment consultant at Paramount Recruitment on 0121 616 3474.
Quality Assurance, Regulatory Affairs, Medical Devices, ISO 13485 jobs, FDA, 21 CDR Part 820 jobs, Scotland, research, 510k, Regulatory Affairs Manager, SOPs, QMS, Quality Management Systems.
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