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International Regulatory Affairs Manager - South East
An excellent opportunity has arisen for an International Regulatory Affairs Manger to come and join the world's largest Medical Devices organisation in the world. This prestigious organisation provide bespoke solutions for Medical Technologies, Medical Imaging, biopharmaceutical and manufacturing technologies to improve the performance and find solutions to deliver better care to people around the world. This Innovating Company are determined to provide the highest quality services to healthcare professional and their patients across the globe.
They are looking for a highly motivated and talented Global Regulatory Affairs Manager to continue the successful of their high prestigious organisations that will hold the following senior responsibilities:
You will be working within the regulatory department to develop and implement global regulatory strategies for products/projects to ensure registration of new products are met at a timely manner. You will provide and collect Regulatory Intelligence input whist working in collaboration with Regional Heads, Segment Heads and CMC group to help develop Regulatory Affairs strategy and operational plans for products.
You will be a responsible regulatory person providing regular regulatory activities related to the projects at hand bringing additional benefits as well as leading a team of Regulatory Professionals. You will liaise with Regulatory Bodies, as required to ensure appropriate (FDA) submissions are done appropriately. Conduct day to day Regulatory activities of the regulatory department.
You will communicate and manage external partner relationship in regards to Regulatory matters, the development and maintenance of all company's regulatory strategy and systems to ensure that good decisions are made. You will also be responsible for providing a substantial amount of knowledge to new projects that are assigned to. You must show knowledge of competitors and any extra knowledge in regulatory expertise that is vital for the business. (E.g. devices)
A Successful candidate must have experience working within a regulatory environment proven analytical skills within a regulated environment; have knowledge of Medical Devices products. You must have experience in conducting scientific and regulatory research, knowledge of general regulatory requirements, show that you are a good communication and are able to negotiate with regulatory agencies and standard notified bodies. Have a depth of understanding of healthcare environment and ability to work independently showing the ability to demonstrate initiative and attention to detail, good problem solving skills is vital 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.
Keywords: Regulatory Affairs, Regulatory Manager, Medical Devices, ISO 13485 jobs, FDA, 21 CDR Part 820 jobs, South East, research, 510k, Auditing, Medical Technology, Medical Information, Informational Technology, Biopharmaceuticals, Regulatory Submissions, Quality Management systems, QMS,RA, International Regulatory Affairs Manager
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