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Job Details

Regulatory Affairs Associate

Company: CROMSOURCE
Location: Germany
Reference: HQ00001179
Closing Date: 22 Mar 18
Type: Contract
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Description     Job Title: Regulatory Affairs Specialist Location: Hamburg, Germany   TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Regulatory Affairs Specialist to strengthen the team of one of our TOP Pharmaceutical client Companies in Hamburg, Germany.     Main Job Tasks and Responsibilities     · Assist with all responsibilities held by the European...

Requirements:

Description

Job Title: Regulatory Affairs Specialist

Location: Hamburg, Germany

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Regulatory Affairs Specialist to strengthen the team of one of our TOP Pharmaceutical client Companies in Hamburg, Germany.

Main Job Tasks and 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

Education and Experience

· 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)

If you have the experience needed for this position, please contact Alexander Sourounis, Senior Consultant TalentSource Life Sciences Unit, and send your CV in WORD format to alexander.sourounis@cromsource.com

Why TalentSource Life Sciences/Cromsource

CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Regulatory Affairs Associate

Apply for this job: Regulatory Affairs Associate

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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