Quality & Regulatory Affairs Specialist

1 giorno fa


Francavilla al Mare, Abruzzo, Italia H2H ADVISORY BENEFIT CORPORATION A tempo pieno

Job Title: Quality & Regulatory Affairs Specialist

About Us: H2H Advisory Benefit Corporation is a leading provider of innovative solutions for the healthcare industry.

Job Summary: We are seeking a highly skilled Quality & Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in our products and services.

Key Responsibilities:

  • Gestione della Documentazione Tecnica: Manage technical documentation for commercialized devices, including technical sheets, certificates, and user manuals.
  • Gestione Quality Agreement: Manage quality agreements with suppliers and clients.
  • Gestione Anagrafica Articoli: Manage product inventory in ERP systems (SAP B1).
  • Post Market Surveillance: Handle, manage, and archive complaints, recalls, and field safety notices for commercialized devices.
  • Studio della normativa vigente: Study and analyze current regulations and their evolution in the medical devices sector.

Requirements:

  • Education: Bachelor's degree in Biomedical Engineering or Economics/Law.
  • Experience: At least 1 year of experience in a similar role.
  • Skills: Basic knowledge of product documentation management and regulatory affairs.
  • Location: Francavilla al Mare or Rome.
  • Software Skills: Proficiency in Microsoft Office and Excel.
  • Language: Excellent knowledge of English.

What We Offer:

We provide comprehensive training and development opportunities to help you grow professionally and integrate into our company culture.

We offer a direct contract with the company and a total compensation package commensurate with your experience.



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