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Product and Project Supporter / Documentation Professional  

Posted on : 02 May 2017

Project Description

Product and Project Supporter / Documentation Professional Become documentation responsible in newly established departmentYou will join Device & Packaging  an integrated part of Global R&D. After one year of existence we are now ready to take the next big leap forward, and we need you on our exciting growth journey. Together with a team of truly passionate and talented colleagues your focus will be to develop and maintain documentation concerning injection devices. If you are looking for an opportunity to be part of a small and competent team where you can unfold your ideas and have massive impact, now is your time to act.Keep us in compliance with regulatory requirementsAs the department s Documentation Professional your overall focus will be to ensure that our documentation is kept updated and in compliance with regulatory requirements from EU, US and other regions. As requirements from authorities are undergoing major changes, now and in the years to come, keeping you updated across directives and legislation will be an important task.The job will span competences across Design Control, Regulatory Affairs and Quality Assurance.More specifically your tasks will be to:Keep documentation for marketed injection devices updated and inspection readySupport development projects regarding documentationIntegrate internal and external development documentation in LEO systemsDeliver documentation support regarding deviations, complaint handling etc.Act as support during auditsRepresent Injection Devices in Life Cycle Management groups / Product Support groupsAs we are building the new department you can look forward to influence your own job as well as overall methods, systems and procedures in the team. You will work especially close together with the department s Product Owner for Pre-Filled Syringes and other documentation approvers.Technical understanding and a strong interest in working with documentationIdeally, you have some years  experience from working with documentation concerning injection devices or other drug-device combination products. If so, you have knowledge of Design History Files / Technical Files and Module 3 documentation and the related legislation and standards.Alternatively, you are newly graduated at master s level in the technical domain and additionally bring a solid technical understanding backed by a strong motivation for working with complicated documentation  and the energy and skillset needed to learn a lot of new stuff in a short amount of time.Regardless of your background, you have a strong interest in working with documentation, a structured way of working as well as a high attention to details. At the same time you are not afraid to make the necessary decisions to uphold momentum and getting things done. As you will work together with multiple people you must thrive on engaging proactively with stakeholders in a constructive and collaborative manner. Finally, you must bring a solid command of English, written and spoken.About Injection Devices  your new departmentYou will join a very dedicated team of 6 highly skilled colleagues, with more to come, at the LEO headquarters in Ballerup, Greater Copenhagen. Our focus is to develop and market state-of-the-art user friendly and differentiated injection solutions to patients all over the world. We work in a friendly and easy-going atmosphere where good collaboration based on mutual respect is a key virtue.We look forward to receiving your application.

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