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Open nowPosted 8 days ago

Responsable Affaires réglementaires et qualité - Dispositifs médicaux H/F

RH Partners72 open roles

Pay
€50,000 a year
Where
BELFORT, Bourgogne-Franche-Comté, France
Work mode
On site
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Your applicationOpen nowResponsable Affaires réglementaires et qualité - Dispositifs médicaux H/FRH Partners · BELFORT, Bourgogne-Franche-Comté, France
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The clock on this job

Early applications get read.

13.3% of postings close within 7 days. Measured by our own scanner across the market. RH Partners postings stay open a median of 20 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.6%3 days
  3. 13.3%7 days
  4. 21.3%14 days
  5. 35.7%30 days
  6. 59.1%60 days
This job: posted 8 days ago

RH Partners median: 20 days open

The posting

Assembleur et distributeur de dispositifs de perfusion et de nutrition entérale, IMM France (International Medical Mediation) est une PME française de référence sur son marché et située à Belfort (90).

Depuis 30 ans, IMM France est aux côtés des professionnels de santé et leur proposons des dispositifs médicaux répondant aux plus hauts standards d’exigence. Présent sur la prise en charge des patients à domicile et en milieu hospitalier, nous développons des dispositifs permettant de réaliser antibiothérapie, hydratation ou chimiothérapie à domicile, le patient conservant ainsi une qualité de vie optimale.

Afin de soutenir notre développement, nous recherchons notre nouveau Responsable Affaires Réglementaires et Qualité h/f.

Sous la responsabilité de la Dirigeante,

  • Vous êtes garant de la conformité réglementaire de nos dispositifs médicaux au regard des exigences des normes MDR 2017/745, LEA et de la transparence.
  • Vous êtes responsable du respect des normes, des exigences qualité et sécurité, ainsi que de la performance de nos produits.
  • En relation avec l’organisme certificateur, vous pilotez l’obtention de la norme ISO 13485. Vous établissez une veille réglementaire pour faire certifier nos produits dans divers pays européens.
  • Vous supervisez les actions liées à la matériovigilance et à la vigilance sanitaire.
  • Vous participez au pilotage d’études cliniques et animez des formations et webinaires à destination de nos clients.
  • Vous développez notre politique RSE et managez deux chargées de missions.

Vous disposez d’un Bac+5 en affaires réglementaires et/ou qualité, ainsi que d’une première expérience probante d’au moins 5 ans en laboratoire pharmaceutique ou autre société dans le D.M. Vous maîtrisez les normes MDR et ISO 13485.

Vous aspirez à intégrer une structure à taille humaine capable de vous impliquer dans un projet de développement ambitieux. Vous êtes force de proposition et appréciez le travail en équipe. Organisé, rigoureux et méthodique, vous savez évoluer dans un environnement réglementaire exigeant. Vous êtes disponible pour participer à des congrès ou autres événements. Une bonne pratique de l’anglais est indispensable.

Poste basé à Belfort (90).

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