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Job Details

Regulatory Affairs Specialist - Devices

Company: ProClinical Ltd
Location: High Wycombe
Reference: RA.PD.14359
Closing Date: 28 Nov 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Here is a chance to join one of the most globally known pharmaceutical organisations, who is looking to hire a Regulatroy Affairs Specialist based in Berkshire, UK. This job will be working a top 10 pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries. Providing Regulatory Affairs support to one of the company's European Authorised Representatives (EAR). ...

Requirements:

Here is a chance to join one of the most globally known pharmaceutical organisations, who is looking to hire a Regulatroy Affairs Specialist based in Berkshire, UK. This job will be working a top 10 pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries. 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.

Job 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

Skills and Requirements:

  • 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)

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Regulatory Affairs Specialist - Devices

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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