IVDR Product Assessor

il y a 2 semaines


Paris, Île-de-France SGS Temps plein
Job Title: IVDR Product Assessor

At SGS, we are seeking an experienced Regulatory Expert to join our team as an IVDR Product Assessor. As a key member of our regulatory team, you will play a crucial role in ensuring the compliance of in-vitro diagnostic medical devices with the European In Vitro Diagnostics Regulation (IVDR).

Key Responsibilities:
  • Conduct thorough reviews of technical files for Class A, B, and C devices to ensure compliance with the IVDR.
  • Identify and document non-compliance issues and work with manufacturers to rectify them.
  • Provide support for CE marking activities and contribute to the training and qualification of junior staff.
  • Communicate effectively with team members, clients, and stakeholders to minimize regulatory risks.
  • Stay up-to-date with relevant technologies, regulations, and best practices.
Requirements:
  • At least 4 years of experience in the healthcare industry or related activities.
  • Minimum 2 years of direct experience in the design, manufacture, testing, or utilization of in-vitro diagnostic devices or relevant scientific research.
  • Knowledge of IVR/IVS/IVP/IVD competence codes for IVDR.
  • Degree or equivalent qualification in a relevant technical discipline.
  • Strong written English skills and proficient communication skills.
  • Demonstrated skills in independent learning.
Desirable Skills:
  • Experience with medical device development life cycle processes and regulatory submissions.
  • Knowledge of ISO 13485 and ISO 14971 standards.
  • Broad experience covering various diagnostic assay types and technologies.
  • Prior experience in conducting product technical documentation assessments for a Conformity Assessment Body or Notified Body.

At SGS, we offer a dynamic and supportive work environment, flexible schedule, and comprehensive benefits platform. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.


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