Quality and Regulatory Affairs Coordinator (H/F)

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Publiée le 25.05.2018

Entreprise

Site Internet: http://www.africawork.com
Secteur d´activité:
Informatique, SSII, Internet
Intérim, recrutement
Offres d´emploi:Voir toutes nos annonces
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Détails de l'annonce

Poste proposé : Quality and Regulatory Affairs Coordinator (H/F)

We are looking for our Client, a Pharmaceutical Multinational Company, a Quality and Regulatory Affairs Coordinator - West, North / French, Central African countries.

MAJOR DUTIES:

Regulatory

Assists the Regulatory and Quality Manager:

  • In supporting business operations for product registrations within the defined territory;
  • With the development of registration plans in accordance with the Company Africa business plans;
  • With the facilitation of all registrations of the Company products in Affiliate and Distributor countries in the defined territory;
  • With the facilitation of all registrations of Third Party products distributed by the Company Affiliates in the defined territory;
  • In providing visibility and reporting of ongoing product registrations and its status to other stakeholders with the use of the product registration trackers where required;
  • In the communication of expected product design changes received from Legal manufacturers onto distributors and authorities, collects such information from distributors and authorities on their impact and informs the Legal manufacturer and distributor on actions resulting from these changes;
  • In communicating and clarifying when required, the registration requirements to the Regulatory and Quality Manager, VP RA Africa Latin America and through to the Legal Manufacturers;
  • In communicating and informing the Regulatory and Quality Manager, VP RA Africa and the Company legal manufacturers of relevant expected regulatory changes, and keeping abreast of such changes in the defined territory;
  • with providing updates to registration requirements into GRID for Africa (Company Regulatory Database) through regulatory intelligence gathered via Commercial team, Distributors and authorities in the designated territory.

Quality

  • Ensures that all Global Quality Procedures applicable to the region are implemented and maintained in accordance to procedure, through periodic audits and in country visits;
  • Assist in the on boarding of new distributors for the territory and implement Distributor Compliance program in the designated territory;
  • Perform Distributor Audits as per Program, Identify risks that impact Quality on Company products and services and work with Distributors on improvements for risk aversion;
  • Assist the Regulatory and Quality Manager in the planning, implementation, monitoring and close out of  field corrective actions (FCAs) in the affected designated territory;
  • Provides periodic updates of FCA status to Regulatory and Quality Manager and other stakeholders in the designated territory;
  • Assist the Regulatory and Quality Manager in product modification reporting  to regulatory Authorities within the defined territory, as required.
Profil recherché pour le poste : Quality and Regulatory Affairs Coordinator (H/F)
  • Medical Technology Diploma / Bachelor’s Degree in Science or equivalent;   
  • 3-5 Years experience within the medical industry in Quality / Regulatory/ Product management functions;
  • Familiar with ISO Quality System standard concepts and procedures will be advantageous;
  • Insight of the Regulatory Requirements of the region;
  • Must be willing to travel;
  • Competent in Word and Excel.

 

Critères de l'annonce pour le poste : Quality and Regulatory Affairs Coordinator (H/F)
Métier:
Métiers de la santé et du social
Production, maintenance, qualité
Secteur d´activité:
Santé, pharmacie, hôpitaux, équipements médicaux
Type de contrat:
CDI
Région:
Casablanca
Ville:Casablanca
Niveau d'expérience:
Expérience entre 2 ans et 5 ans
Niveau d'études:
Bac+5 et plus
Nombre de poste(s):1

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