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(2018-01-12 11:11:05)


Regulatory Affairs Specialist ()




Job Title: Regulatory Affairs Specialist Location: Hamburg, Germany   TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Regulatory Affairs Specialist to strengthen the team of one of our TOP Pharmaceutical client Companies in Hamburg, Germany.     Main Job Tasks and Responsibilities     · Assist with all responsibilities held by the European Authorised Representative based in Germany   · Maintain internal databases of currently registered medical devices   · Prepare status updates for senior management on the progress of medical device registrations completed in Germany for the EAR   · Access the UMDNS database to identify and allocate codes/terms to the company s existing medical devices   · Navigate internal electronic systems to locate regulatory documentation and data   · Navigate internal regulatory documentation to identify and extract data needed for EAR registrations   · Coordinate with other internal stakeholders to locate cross-functional data and where needed, review and feedback on compiled data and documentation   · Review and update existing procedures where needed   · Generate and maintain status reports on EAR activities to be provided to German Authorities   · Submission of regulatory documentation and data into the German Regulatory system   · Managing and responding to German Authority questions   · Rescind existing medical device registrations for the EAR wherever a product line is discontinued   · Assist with other administrative Regulatory tasks to support the existing EU Regulatory Strategy team as needed   · Keep EU affiliates informed about changes and forward documentation as needed   · Support Notified Body change notifications   Education and Experience   · Ability to use multiple complex databases simultaneously   · Ability to comprehend scientific and clinical data   · Ability to manage large amounts of data comprehensively   · Ability to interact with personnel across the organization, across departments and seniority   · Ability to interact professionally and diligently with government staff   · Ability to work independently and manage high workload efficiently   · German / English language fluently in writing and verbal   · Basic knowledge of European Medical Device Regulations (MDD, MDR, ISO 13485)   If you have the experience needed for this position, please contact Alexander Sourounis, Senior Consultant TalentSource Life Sciences Unit, and send your CV in WORD format to     Why TalentSource Life Sciences/Cromsource   CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.        Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.        


Cromsource GmbH
Herr Alexander Sourounis
Borchersstrasse 20
52072 Aachen

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