Regulatory Affairs

Recruiter
KELLY SERVICES LIMITED
Location
Portsmouth
Salary
£0 to £60000
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Contract
Hours
Full Time
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Job Title: Regulatory Affairs Specialist
Salary: £60,000 PAYE/ £77,600 LCC
Location: Wokingham
Duration: 4 months

Your new Company
Kelly Services are delighted to be working with our Client, a global medical devices company based in Wokingham and easily accessible from London in searching for a German Speaking Regulatory Affairs Specialist to join their organization on a 4 month contract.
This is an excellent opportunity for the ideal candidate to grow with this global organization and work alongside one of the world's best recognized global companies.
As well as working in an environment of knowledge and continuous learning you will benefit from the onsite facilities that the company offers to all employees including on-site gym, free parking and subsidized canteen.

Your new Job

- 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 you need to succeed

- 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)

What this opportunity will do for you
This is an excellent opportunity for an experienced Regulatory Affairs specialist to showcase the strong understanding of European medical devices regulations. You will be joining an organisation that believes in their employees by providing them with knowledge and a supportive learning environmentto grow and develop their individual skills.
As well as thefriendlyculture, thereare also some greatsite benefits which include:

- on-site free parking
- Subsidized canteen
- on- site gym
- Annual holiday leave

If you would like to hear more about this role please get in contact with me on Phone number removed

Kelly Services are an Equal Opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.Kelly Services are acting as an Employment Agency in relation to this job.