Regulatory Affairs Specialist - German speaking

C.K. Associates Limited
£30 to £40
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Mary Bolt is recruiting for a Regulatory Affairs Specialist to join a world leading medical device organisation that develop and manufacture speciality products for all surgical fields at their site based in Berkshire on a contract basis.

The main purpose of the role will be to:
-Provide Regulatory Affairs support to one of the company's European Authorised Representatives (EAR) and file and maintain medical device registrations in the relevant German national database, maintaining internal documentation and communicating registration information to relevant stakeholders.
-Assist with all responsibilities held by the European Authorised Representative based in Germany and prepare status updates for senior management on the progress of medical device registrations completed in Germany for the EAR.
-Navigate internal electronic systems to locate regulatory documentation and data and navigate internal regulatory documentation to identify and extract data needed for EAR registrations as well as coordinating with other internal stakeholders to locate cross-functional data and where needed, review and feedback on compiled data and documentation

Further responsibilities will include:
-The submission of regulatory documentation and data into the German Regulatory system
-Generating and maintaining status reports on EAR activities to be provided to German Authorities as well as 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 and support Notified Body change notifications

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level or above in life science of a related field and experience of working within Regulatory Affairs and Medical Devices including Basic knowledge of European Medical Device Regulations (MDD, MDR, ISO 13485).
-Fluency in both German and English (written and spoken)
-The ability to use multiple complex databases simultaneously, comprehend scientific and clinical data and manage large amounts of data comprehensively as well as the ability to interact with personnel across the organization, departments and seniority.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL40561 in all correspondence.