...Expérience confirmée dans la routine de laboratoire et le management d’une équipe de techniciens dans un laboratoire accrédité selon la norme ISO 15189.
Esprit d’analyse et organisation pour gérer les priorités.
Grande capacité d’adaptation.
Orientation pour le service...
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CDI
...Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR and other applicable regulations.
* Actively monitor effectiveness of the quality management system and propose...
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...Indesign for document modification.
* Skilled in using Excel for the management of product data in regulatory databases.
* Knowledge of ISO 13485:2016 and other relevant regulatory standards.
* Bachelor's degree in a relevant field (Technical Writing, Engineering,...
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...a medical devices company ;
* Experience with vigilance, post-market surveillance and complaint management is required ;
* Knowledge of medical devices regulations (EU-MDR, ISO 13 485...) ;
* Audit experience is a plus ;
* Proficiency in French and English is mandatory.
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Optimiso Group SA apporte aux entreprises des solutions pour le contrôle interne, les certifications ISO, l'organisation interne et le management des risques. Ces solutions se traduisent par le logiciel Optimiso Suite ainsi que des services sur-mesure de conseil, réalisation...
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...trainings.
Description du profil :
Minimum 3 years of experience within the medical device industry;
Strong knowledge of ISO 13485, ISO 14971, 21 CFR, MDR;
Experience with submitting technical files for Europe & the US;
French and English are mandatory...
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...metals and stones by participating in umbrella organizations and standards bodies, such as the RJC, but also the Fédération Horlogère and ISO.
Regarding Responsible Sourcing training, one of the department’s primary missions is to protect the Group’s reputation....
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