Senior Regulatory Affairs Associate - Medical Devices - Scotland.
Salary: £30,000 -£35,000 plus Benefits
A fantastic opportunity has become available for a reputable organisation based in Edinburgh. This well established bio-manufacturing organisation is seeking a Senior Regulatory Affairs Associate to come join their rapidly expanding division and provided good manufacturing practice in their two company sites.
This international renowned life sciences organisation currently produce and manufacture high class medical devices products within the IVD and life sciences sector. This is a prestigious and well established organisation looking for a talent to come and join their success.
The primary role of the Regulatory Affairs Specialist is to deal with new and existing products, facilitate complaints and approvals. The job roles include maintenance of the company's device listing and establishment registration with FDA, prepare regulatory dossiers to support the products licenses and adhere to all compliance procedures. They may be involved in setting up, monitoring and reporting clinical studies. Along with working closely with other regulatory personal to ensure global market requirements are fairly addressed. You will also be a part of Regulatory labelling requirements, showing substantial amount of knowledge of FDA Medical Devices (ISO 13485) regulations.
A Successful candidate must have experience working within a regulatory environment, have knowledge of class III Medical Devices and other medical devices products and IVD knowledge would be an advantage. You must have experience at preparing and submitting 510K applications, knowledge of cGMP and 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, bonus and a 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.
Keywords: Design Compliance jobs, Quality Assurance jobs, Regulatory Affairs jobs, In vitro diagnostics jobs, Medical Devices jobs, ISO 13485 jobs, FDA, 21 CDR Part 820 jobs, Scotland jobs, research, 510k jobs, Regulatory Affairs specialist jobs, IVD jobs
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