Senior Regulatory Affairs Specialist

  • Wrocław, dolnośląskie
  • Powstańców Śląskich 95, Wrocław, Polska pokaż mapę
  • Specjalista
  • Pełny etat
  • 12.08.2019
  • Ważna jeszcze 21 dni (do 11.09.2019)

    Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

    QIAGEN is one of the world’s leading biotechnology companies. With our sample to insight solutions that unlock valuable molecular information from biological samples, QIAGEN helps to improve healthcare and safeguard our societies, enables the development of new medicines and paves the way for scientific breakthroughs.

    Join the revolution – and see how you can make a difference!

    Senior Regulatory Affairs Specialist

    Job ID #:  11094

    Functional Area: Regulatory / Clinical / Medical Affairs             Location: Wroclaw (Breslau), Poland

    Duration: unlimited                                                                      Employment Type: Regular Full-Time

    • Prepare regulatory submissions for EU IVD Regulations for QIAGEN IVD products that include RT-PCR test kits for infectious disease viral markers. Other products include reagents and instrumentation for nucleic acid extraction from biological samples that are linked to downstream IVD test applications.
    • Review product labeling and promotional literature for regulatory compliance.
    • Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with EU, and other regulatory agencies in the least burdensome manner.
    • Interface with regulatory agencies for inquiries and issues.
    • Review and prepare clinical reports, R&D protocols and technical reports and other company documents (including labeling and marketing materials, when applicable) for use in regulatory submissions and in response to queries from the regulators. 

    Position Requirements

    • Minimum Bachelor’s Degree in a scientific discipline.
    • Molecular biology or clinical laboratory experience would be a strong asset in the position.
    • RAC certification preferred, but not required.
    • At least 4 years experience in the medical device, pharmaceutical or biologics industry, with at least 2 years experience in Regulatory Affairs preparing submissions, preferably in the area of IVDs.
    • Very good knowledge of English. 

    Personal Requirements

    • Must have strong interpersonal and communication skills with strong English language ability.
    • Able to communicate effectively with employees at all levels of the QIAGEN organization as well as with key individuals outside the organization. These outside contacts may include FDA reviewers, consultants, and representatives from clinical sites or other IVD or pharmaceutical companies.
    • Demonstrated strong attention to detail, as well as the ability to work under pressure to meet project deadlines.
    • Demonstrated organizational, planning and prioritizing abilities are required, as well as strong technical writing ability.
    • Ability to work on complex problems and exercise sound science-based decision making in developing regulatory strategies and solutions to regulatory problems.
    • Thrive in a fast paced work environment, while possessing the ability to quickly change priorities and perform multiple tasks simultaneously.

    We offer

    • Possibility to develop in an international company.
    • Attractive office location in Sky Tower.
    • Attractive benefits package.
    • Language classes.
    • Private medical care.
    • Group Life Insurance.
    • Friendly atmosphere.
    • Happy Monday :)

    If this interdisciplinary challenge appeals to you, you can expect a highly motivated team that is looking forward to your support! Please apply online, quoting the reference number, with your complete application documents as well as your earliest starting date and salary expectations.

    We look forward to hearing from you!