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Open nowPosted 86 days ago

RA/QA Associate

EURES job mobility portal61,081 open roles

Where
Delfzijl en omgeving, Netherlands
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Your applicationOpen nowRA/QA AssociateEURES job mobility portal · Delfzijl en omgeving, Netherlands

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on EURES job mobility portal's own form.

The reply lands in your private mailbox

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The clock on this job

Early applications get read.

7.9% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.9%7 days
  4. 14.2%14 days
  5. 34.1%30 days
This job: posted 86 days ago

The posting

RA/QA Associate - Laboratorium Wil jij bijdragen aan de kwaliteit en veiligheid van innovatieve medische hulpmiddelen? Heb jij een achtergrond in Regulatory Affairs of Quality Assurance en werk je graag in een dynamische, internationale omgeving? Dan hebben wij de perfecte uitdaging voor jou! Jouw functie Als RA/QA Associate speel je een belangrijke rol in het waarborgen van de kwaliteit en naleving van wet- en regelgeving voor medische hulpmiddelen. Je ondersteunt zowel de Regulatory Affairs- als de Quality Assurance-activiteiten en zorgt ervoor dat producten en processen voldoen aan de geldende wetgeving, kwaliteitsnormen en interne procedures. In deze veelzijdige functie ben je verantwoordelijk voor het opstellen van regelgevende documentatie, het ondersteunen van audits en het samenwerken met verschillende afdelingen om de hoogste kwaliteitsstandaarden te waarborgen. Wat ga je doen? In deze functie houd je je onder andere bezig met: - Het opstellen, samenstellen, beoordelen en onderhouden van PMA-aanvragen (Premarket Approval) en bijbehorende regelgevende documentatie. - Het ondersteunen van registratietrajecten en conformiteitsbeoordelingen voor hoog-risico medische hulpmiddelen binnen de Europese Unie. - Het coördineren van de documentatie die nodig is voor CE-markering en beoordelingen door Notified Bodies . - Het uitvoeren van ISO-gapanalyses en het ondersteunen bij de implementatie van corrigerende maatregelen. - Het voorbereiden van pre-approval audits door ervoor te zorgen dat documentatie, processen en registraties volledig en auditgereed zijn. - Het ondersteunen van interne en externe audits, waaronder de voorbereiding, coördinatie en opvolging van auditbevindingen. - Het ondersteunen bij wijzigingsmeldingen aan relevante interne en externe stakeholders. - Het bijdragen aan de continue verbetering van het Quality Management System (QMS) . - Het nauw samenwerken met verschillende afdelingen om de naleving van wet- en ...

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