IVDR Product Assessor
il y a 2 semaines
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.
- 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.
- 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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