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Regulatory Affairs Manager - Medical Devices - Germany
A new job opportunity has come up with one of the medical device companies based in Germany. Their Regulatory department are searching for an experienced Regulatory Affairs Manager to join their team and take on a challenging role within a nice working environment. This is an excellent opportunity for experienced Regulatory Specialist to step up and take their experience to the next level!
As a Regulatory Manager you will be responsible for maintaining all Technical files and Master files for all classes of Medical Devices, liaising with Regulatory Bodies, conducting day to day Regulatory activities of the regulatory department, reviewing labelling, packing and marketing literature, communicating and managing external partner relationship in regards to Regulatory matters, developing and maintaining company Regulatory strategy and systems to ensure appropriate compliance, writing Regulatory documentation for Regulatory submissions for global markets and working on Quality Management systems (QMS).
A Successful candidate must have experience working within a regulatory environment and have knowledge of Medical Devices products. Experience in preparing and submitting 510K applications, knowledge of cGMP, FDA & PMA. You will need to show the ability to demonstrate initiative and attention to detail, good organisational skills and the ability to work to deadlines across multiple simultaneous projects. You will be fluent in both German and English and be eligible to work in Germany.
For more information please do not hesitate to contact Marketa Smelhausova on 0044 (0) 207 940 2103 or send your application to email@example.com. I look forward to receiving your application!