IVDR Product Specialist

7 dni temu


Warszawa, Mazovia, Polska SGS Pełny etat
Job Description

Overview

SGS is seeking an experienced IVDR Product Assessor to join our team of regulatory professionals. As an expert in clinical diagnostic technologies, you will be responsible for ensuring that patients across Europe have access to safe and effective diagnostic tests.

Key Responsibilities

  • Assess in-vitro diagnostic medical devices for compliance with the European In Vitro Diagnostics Regulation (EU IVDR).
  • Review technical documentation submitted by manufacturers to ensure compliance with regulatory requirements.
  • Identify and rectify compliance issues in device technical files.
  • Provide support for CE marking activities and contribute to the training and qualification of junior staff.
  • Communicate effectively with stakeholders regarding product assessments and minimize regulatory risks.

Requirements

  • At least 4 years of professional experience in healthcare products or related activities.
  • Knowledge of IVDR/IVS/IVP/IVD competence codes and relevant technical disciplines.
  • Strong written English skills and proficient communication skills using modern electronic platforms.
  • Demonstrated skills in independent learning and a keen eye for detail.

Desirable Skills

  • Direct experience with medical device development life cycle processes and regulatory submissions.
  • Experience with clinical studies and clinical performance evaluation of in-vitro diagnostic devices.
  • A broad base of experience covering different diagnostic assay types and technologies.
  • Prior experience as a technical file reviewer for a Conformity Assessment Body/Notified Body.


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