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Regulatory and Quality Associate - L

Employer
ClinChoice
Location
Germany
Salary
Competitive
Start date
17 May 2019
Closing date
29 May 2019

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Description:
Description

Job Title: Regulatory and Quality Specialist

Location: Hamburg, Germany

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

Main Job Tasks and Responsibilities

  • Calibration and maintenance procedures for Laboratories within a local CAPA.

  • 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

    Education and Experience

  • Successfully completed technical or scientific education or college degree preferred

  • Relevant work experience, preferably in the range of Regulatory Affairs and Quality Management

  • Experience in the implementation of international regulatory processes, quality management, in compliance with DIN EN ISO 13485

  • Strong knowledge in MS Office

  • Very good English-knowledge (spoken and written)

  • Initiative, independently working manner and strong communication skills

    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.

    Skills: Regulatory Location: Germany

  • Company

    ClinChoice

    ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

     

    We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

     

    Company info
    Website
    Telephone
    +44 1628 566121
    Location
    Suite G48
    268 Bath Road
    Slough
    Berkshire
    SL1 4DX
    United Kingdom

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