Diagnostic Regulatory Specialist
hace 2 semanas
Company Overview
Sgs, a world-renowned testing, inspection and certification company, empowers a safer and more interconnected world. Our Innovation Factory spearheads digital innovation initiatives across Sgs, delivering solutions at scale and speed.
Job Description
As a Diagnostic Regulatory Specialist, you will leverage your expertise in clinical diagnostic technologies to ensure patients across Europe have access to safe and effective diagnostic tests. Your role will involve assessing in-vitro diagnostic medical devices for strict compliance with the relevant European laws (EU IVDR; Regulation 2017/746). You will conduct reviews of manufacturers' technical documentation as part of the CE marking process, requiring a keen interest in and deep understanding of product technologies, knowledge of clinical application, and attention to detail.
Key Responsibilities:
- Conduct technical file reviews against the EU In-vitro Diagnostics Regulation for Class A sterile, Class B, and Class C devices within a defined timeframe, verifying compliance of technical documentation submitted by manufacturers against regulatory requirements.
- Identify, document, and seek to rectify instances where device technical files deviate from compliance with applicable requirements under the IVDR.
- Support CE marking activities within Sgs, contribute to training and qualification of junior staff, and develop comprehensive training materials.
- Communicate effectively with team members, clients, and stakeholders regarding product assessments, working diligently to minimize regulatory risks associated with in vitro diagnostic device certification.
- Expand and keep up-to-date knowledge of relevant technologies, regulations, international standards, and best practice guidance documents.
Qualifications
We are seeking an experienced candidate with:
- At least 4 years of professional experience within the domain of healthcare products or related activities.
- A minimum of 2 years involving direct engagement in design, manufacture, testing, or utilization of specific in-vitro diagnostic devices and technologies, or relevant scientific research.
Estimated Salary:
$115,000 - $150,000 per annum based on location and industry standards.
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