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Open nowPosted 26 days ago

Regulatory Affairs Engineer

EURES job mobility portal552,729 open roles

Where
Twente, Netherlands
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Your applicationOpen nowRegulatory Affairs EngineerEURES job mobility portal · Twente, Netherlands
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The clock on this job

Early applications get read.

9.8% of postings close within 7 days. Measured by our own scanner across the market. EURES job mobility portal postings stay open a median of 6 days.

Share of postings closed within
  1. 1.9%1 day
  2. 3.9%3 days
  3. 9.8%7 days
  4. 15.6%14 days
  5. 33.9%30 days
This job: posted 26 days ago

EURES job mobility portal median: 6 days open

The posting

Benchmark logo Regulatory Affairs Engineer - Hybride - - Almelo , Overijssel , Nederland - € 4.159 - € 7.010 per maand - Quality Management Functieomschrijving Jij bent het geweten achter technologie die ertoe doet. Of het nu gaat om in-vitro diagnostische systemen (IVD), life-sustaining devices of complexe high-tech toepassingen binnen de defensie-, en semiconductorindustrie: jij zorgt ervoor dat producten gedurende hun volledige levenscyclus aantoonbaar voldoen aan wet- en regelgeving, normen en klanteisen. Je bewaakt compliance, beheerst risico's en maakt het mogelijk dat producten veilig, betrouwbaar en succesvol worden ontwikkeld, geproduceerd en toegepast. Als Regulatory Affairs Engineer vertaal je complexe regelgeving naar heldere keuzes voor projectteams en klanten. Je beoordeelt risico's, bepaalt de regulatory strategie en zorgt dat de juiste onderbouwing aanwezig is om producten wereldwijd te registreren, vrij te geven en compliant te houden. Dankzij jouw expertise kunnen innovatieve producten veilig en compliant worden ingezet in omgevingen waar betrouwbaarheid geen optie, maar een absolute voorwaarde is. Waar houd jij je mee bezig? - Vertalen van regelgeving en klanteisen naar uitvoerbare product- en kwaliteitseisen. - Bepalen en bewaken van de regulatory strategie binnen ontwikkel- en wijzigingstrajecten. - Adviseren van klanten en projectteams over compliance, risico's en markttoelating. - Beoordelen en vrijgeven van kritische technische en kwaliteitsdocumentatie. - Uitvoeren van impactanalyses bij ontwerp-, proces- en documentwijzigingen. - Goedkeuren van validaties, kwalificaties en vrijgaveactiviteiten. - Ondersteunen van productintroducties gedurende de volledige productlevenscyclus. - Vertegenwoordigen van Benchmark bij audits, klantreviews en certificeringstrajecten. - Initiëren van verbeteringen om compliance en productkwaliteit te versterken. Deze rol speelt zich nadrukkelijk niet alleen achter ...

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