IVDR Product Assessor

About SGS 🏢

We are SGS – the world's leading testing, inspection, and certification company. Recognized as the global benchmark for sustainability, quality, and integrity, our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer, and more interconnected world. Our Innovation Factory promotes and develops digital innovation initiatives across SGS, delivering solutions at scale and speed. Our mission is to create a better, safer, and connected world by supporting, improving, or augmenting our physical operations with digital technologies.

The Role 🧑‍⚕️

As an IVDR Product Assessor, you'll use your expertise in clinical diagnostic technologies to ensure patients across Europe have access to safe and effective diagnostic tests. Join our growing team of regulatory professionals helping the European healthcare ecosystem navigate the transition to the new European In Vitro Diagnostics Regulation. You will assess in-vitro diagnostic medical devices for compliance with European laws (EU IVDR; Regulation 2017/746), primarily reviewing manufacturers' technical documentation for CE marking. This requires a deep understanding of product technologies, their clinical applications, and meticulous 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, verifying compliance of submitted documentation against regulatory requirements within defined timeframes.
• Identify, document, and work to rectify instances where device technical files deviate from compliance with applicable IVDR requirements.
• Support CE marking activities within SGS, contribute to junior staff training and qualification, and develop comprehensive training materials.
• Communicate effectively with team members, clients, and stakeholders regarding product assessments, diligently minimizing regulatory risks associated with in-vitro diagnostic device certification.
• Continuously expand and update your knowledge of relevant technologies, regulations, international standards, and best practice guidance documents.

What We're Looking For 🔎

• Required:
  • At least 4 years of professional experience in healthcare products or related activities (design/development, manufacturing, auditing, relevant academic research, or clinical settings).
  • Minimum 2 years directly engaging with the design, manufacture, testing, or utilization of specific in-vitro diagnostic devices and technologies, or relevant scientific research.
  • Knowledge encompassing a range of IVR/IVS/IVP/IVD competence codes for IVDR, as defined in Commission implementing regulation (EU) 2017/2185.
  • Degree or equivalent qualification in a relevant technical discipline (medicine, engineering, biomedical science, microbiology, or biochemistry).
  • Proficient communication skills using modern electronic platforms.
  • Strong written English skills.
  • Demonstrated independent learning skills.
• Preferred:
  • Experience with medical device development life cycle processes, regulatory submissions, and relevant standards (ISO 13485 and ISO 14971).
  • Experience with clinical studies and clinical performance evaluation of in-vitro diagnostic devices.
  • Broad experience covering various diagnostic assay types and technologies.
  • Prior experience conducting product technical documentation assessments for another Conformity Assessment Body/Notified Body (technical file reviewer or equivalent).
  • In-depth knowledge of the European regulatory framework on medical devices (on-the-job training provided).

Benefits & Perks 🎉

• Work for a globally recognized and stable company, a leader in the TIC industry.
• Enjoy a flexible schedule and a fully remote work model.
• Access SGS University and Campus for continuous learning.
• Thrive in a multinational environment, collaborating with colleagues from multiple continents.
• Benefit from a comprehensive benefits platform.

Join Us! 🤝

At SGS, we foster an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide opportunities to learn, grow, and fulfill your potential. Apply now to be part of our team!