Regulatory Affairs Specialist

Elevate Direct
11 Nov 2017
18 Nov 2017
Contract Type
Full Time
Regulatory Affairs Specialist/Pinewood, Wokingham/4 Months Contract/28 to 40 GBP (Per Hour) Providing Regulatory Affairs support to one of the company's European Authorised Representatives (EAR). Filing and maintaining medical device registrations in the relevant German national database, maintaining internal documentation and communicating registration information to relevant stakeholders. 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 Required Skills: 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) The Company Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886. If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly. - provided by Dice