158 days ago on day-medical.com

Regulatory affairs specialist (EN)

DAY medical SA

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 Please refer to JobSuchmaschine in your application

Regulatory affairs specialist (EN)

DAY Medical SA, a young company specializing in the manufacture and marketing
of innovative products for medical laboratories and hospitals specializing in
immunohematology (blood group diagnosis) is looking today for its site in

Avenches for an:

Regulatory Affairs Specialist


Your responsibilities:

• You establish the technical documentation of our IVD systems and products;
maintain our documents up to date considering the evolution of the regulatory
• You cooperate with our distributors and representatives in foreign countries to
define the regulatory strategy and respond to the local requirements
• You guarantee the conformity of our portfolio of medical devices IVD with the
European Directives 98/79/EC IVD (CE certification)

Your competences:

• You profit of a scientific education (biology or pharma (bachelor level or equivalent)
and, ideally, with some experience in immunohematology
• You have at least one year of experience in Regulatory Affairs (medical devices,
diagnostic industry) and have a good knowledge of directives and norms applied to
medical devices
• You are either French or German native speaker with excellent communication
skills in English
• Knowledge of FDA (PMA, 510K) would be of advantage

If you are interested in a new evolutionary function in a young and modern
company that offers real development opportunities and attractive conditions of
service, do not hesitate and send us your complete application without delay.

DAY medical SA, Human Resources
Z.I. Est C5 Route de la Plaine 49
CH-1580 Avenches
T +41 26 676 70 00