Regulatory Affairs Specialist

£0 to £40
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
I am currently working on behalf of a global, world-leading Pharmaceutical company who is seeking a German-English bilingual Regulatory Affairs Specialist to join their team at their site in Wokingham.

The successful Regulatory Affairs Specialist will have an excellent command of both written and spoken German and English, and will have at least basic knowledge of European Medical Device Regulations (MDD, MDR, ISO13485).

As a Regulatory Affairs Specialist, you will be given the platform to showcase your knowledge and expertise as you assist with all responsibilities held by one of the company's European Authorised Representatives (EAR) based in Germany. You will also be entrusted with maintaining internal documentation and databases, including accessing databases to identify and allocate codes/terms to the company's existing medical devices, and with preparing status updates for senior management regarding the progress of medical device registrations completed in Germany for the EAR.

In your role as a Regulatory Affairs Specialist, you will also have the opportunity to demonstrate your ability to understand and manage several large data sets simultaneously as you navigate internal systems and documentation to identify and extract the data required for EAR registrations. There will also be the chance for you to put your communication skills to use as you coordinate with other internal stakeholders to locate cross-functional data as required.

You will also hold responsibility for submission of regulatory data and documentation into the German Regulatory system, andfor managingand responding to German Authority queries. Where medical device lines are discontinued, you will also hold responsibility for rescinding their registrations. The role may also include other Regulatory Affairs tasks on an ad hoc basis.

As a successful applicant, you will complement your ability to manage and utilise large and complex data sets with an ability to communicate effectively in both written and spoken English and German with internal colleagues and external bodies, including government staff. You will also have the ability to work independently and manage high workloads efficiently.You will be working for a company which is built upon its exceptional working culture and strong employee values, and will be joining a successful team of skilled and dedicated professionals in a dynamic working environment.

The role is a 4-month contract role initially and will be based in Wokingham, Berkshire.

Also commutable from Bracknell,High Wycombe, Maidenhead, Reading, Slough, and West London.

Kelly Services are acting as an Employment Agency in relation to this role.