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Regulatory Affairs Manager (m/f) nearby Schaffhausen - Oferta z Jobs.pl

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Regulatory Affairs Manager (m/f) nearby Schaffhausen

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  • Regulatory Affairs Manager (m/f) nearby SchaffhausenFor our client, who is offering a multifaceted challenge in a dynamic and international environment we are looking for a Regulatory Affairs Manager. In this regulatory function located in Schaffhausen you will manage and support the following tasks:Your tasks: ?Submissions: Coordination and preparation for new submissions?High intensity of customer communication ?Development of regulatory filing strategies and implementation plans?Regulatory actions?Coordination and preparation of responses to deficiency letters or authority requests?Coordination and preparation of responses of customer requests ?Preparation and submission of Open Parts, Letter of Access, etc.?Regulatory assessments?Regulatory consultation for Quality Assurance?Preparation of FDA?Regulatory support for Audits?Lifecycle managementYour Qualifications:?A minimum of a Bachelor's degree with a minimum of 5+ years of relevant experience in a highly regulated environment or an advanced degree (MS, PhD, etc.) with a minimum of 3+ years of experience is required.?CMC experience would be a plus?Drug development experience would be a plus?A working knowledge of global laws, regulations, and guidance is necessary?Experience in developing regulatory strategies ?Solid understanding of chemistry would be a plus?Good organizational skills and an ability to manage multiple projects, etc.?Good knowledge of EnglishAre you motivated, committed and flexible? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress? Then please send your complete application documents by email to Petra Ognjenovic: case of any further question, please do not hesitate to contact Petra Ognjenovic: .Keywords: Regulatory Affairs, Medical Devices, Zulassung, Medizintechnik, Normen, Petra Ognjenovic, Compliance, CE, FDA, Behörden, Intranet, Lawrence Harvey, Qualitätssicherung, Qualitätsmanagement, Quality, Zulassungen, 510(k)Lawrence Harvey is acting as an employment agency in regards to this position.Visit our website and follow us on Twitter for all live


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