Quality Assurance and Regulatory Affairs Careers

The Quality system and the jobs pertaining to it help guarantee the relevance and efficiency of our work methods to produce the best products and, consequently, the highest level of customer satisfaction.

Regulatory Affairs helps us bring products to market with the competent authorities of all the countries where Stago is represented. The activities of Regulatory Affairs therefore include keeping a regulatory watch and writing manuals and instructions.

Ingénieur / Responsable Qualité Produits

Son rôle :

Il traite les réclamations et les dossiers de réactovigilance,
Il met à jour les spécifications des réactifs dans le cadre de la maîtrise du changement, et contribue à la gestion des risques en phase de post-production.

Sa formation :

Il est titulaire d'un diplôme d'Ingénieur ou d'un Master 2 spécialisé en Biologie, Biochimie ou Pharmacie, et possède une expérience en assurance de qualité et/ou affaires réglementaires dans le secteur industriel.

Regulatory Records Engineer/Manager

Role:

You assure the registration of products and produce the technical documentation for reagents in accordance with the applicable regulations and production constraints.
In this way, you contribute to the marketing of the products and the correct use of reagents by customers.

Qualifications:

You have an engineering degree or Master’s specialised in Biology, Biochemistry or Pharmacy, with experience in medical biology laboratories and/or regulatory affairs.

Regulatory Affairs Engineer/Manager

Role:

You keep a regulatory watch and inform the departments concerned of any regulatory changes.
You check that the standards are applied in your field to guarantee that the products sold comply with the applicable regulations.

Qualifications:

You have an engineering degree or Master’s specialised in Biology, Biochemistry or Pharmacy, with experience in medical biology laboratories and/or regulatory affairs.

Aurélie D, Product Risk Management Engineer (reagents), at Gennevilliers:

"I’ve worked at chez Stago since 2005, with the job of contributing to the safety of our range of reagents, particularly from the patient’s point of view. I particularly like the diversity of contacts across all departments that my job involves. In fact I deal with a large number of people from R&D, Production, Quality assurance and Law enforcement. I regularly meet them as the leader of working-parties and I get consulted from time to time on very specific issues. I can also help as support and trainer in the management of product risks. By being involved in all the stages in manufacturing the product, I’ve acquired excellent knowledge of how the company operates and of all our products."