• Regulatory Affairs Specialist

    Localisation CH-FR-Cressier
    Identifiant de la demande
    2018-7448
    Nombres de postes
    1
    Catégorie
    RA
  • Présentation

    Bio-Rad is an innovative company and thanks to its laboratory diagnostic systems world leader in the field of blood group serology.

     
    Our company is involved in the supply of high-quality products and services intended for diagnostic laboratories. Independence, innovation and commitment are the fundamental values that permeate our company culture, as well as a strong orientation towards our customers and a multicultural environment.

     

    Bio-Rad in Cressier/Switzerland is looking for a Regulatory Affairs Specialist 100%.

    Responsabilités

    • You ensure the compliance of our IVD medical device portfolio with the requirements of the European Directives and regulations 98/79 / EC and 2017/746 (CE marking) throughout the product life cycle (development, manufacture, placing on the market).
    • You build up the technical documentation of our IVD reagents and systems and update it in light of changing regulatory requirements.
    • You are responsible for coordinating and developing registration dossiers for the worldwide registration of our products as soon as possible.
    • You work closely with representatives of our subsidiaries (Asia Pacific, Latin American, Eastern Europe, Middle East, and Russia) to define the regulatory strategy and meet local requirements.

    Compétences

    • You benefit from a scientific university degree in biology or pharmacy (Bachelor or equivalent level) with ideal knowledge of immuno-hematology.
    • You stand out by your writing skills and can clearly present complex situations (both written and oral).
    • You have good skills to analyze and synthesize technical data.
    • You have 2 to 4 years of experience in regulatory affairs (pharmaceutical or diagnostic industry) and have a good knowledge of regulations and standards for medical devices.
    • US/FDA regulatory knowledge is an asset (PMA, 510k).
    • You are native French or German with good knowledge of the other language and you also have a very good command of spoken and written English.

    Do you see your next professional challenge in this position? We look forward to receiving your application. If you click on "Apply", you have the option of submitting your complete cover letter, resume and credentials in a coherent PDF or Word document.

     

    To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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