SGS: Product Assessor / Senior Product Assessor – Active Devices

remote-job.net Job Summary: 💶 Salary: Not specified ⏰ Weekly working hours: Full-time 🔍 Recommended experience: Senior 🎓 Recommended education: Bachelor's or Master's degree in Medical Technology, Biomedical Engineering, Electrical Engineering, or similar (preferred) 🏭 Industry: Medical Technology 📋 Key Responsibilities: Leading and developing a small team of Product Assessors. Conducting technical documentation reviews for active medical devices in compliance with MDD/MDR. Coordinating with interdisciplinary teams to ensure high service quality. ✅ Key Requirements: Experience as Product Assessor/Technical File Reviewer in a Notified Body for active devices. At least 4 years of relevant professional experience, including ≥2 years in design/manufacturing/testing of medical devices. Knowledge of relevant standards (EN 60601, EN 62304, EN 62366) and good written English skills. About the company: SGS is the world's leading company for testing, inspection, and certification (TIC). We are recognized as a global benchmark for sustainability, quality, and integrity. Our approximately 99,600 employees work in a network of about 2,600 offices and laboratories to enable a better, safer, and more interconnected world. The headquarters for this position is located at Aleje Jerozolimskie 146A, 02-305 Warsaw, Poland. The role is part of the Medical Device team within the global SGS network. Responsibilities: - Leading, supporting, and coaching a small, globally dispersed team of Product Assessors. - Conducting comprehensive technical documentation reviews and ensuring compliance with EU-MDD/MDR and relevant standards. - Collaborating with internal, cross-functional teams to improve efficiency and quality. - Monitoring the technical competence, KPIs, and well-being of the team; providing feedback and support for issues. - Conducting recruitment activities (CV review, interviews) and assisting in onboarding new employees. - Developing and delivering training internally or externally. - Assisting with technical inquiries and sales-related questions in the field of Active Medical Devices. - Ensuring high-quality service delivery within the SGS network for medical device certifications. Requirements: - Experience as a Product Assessor / Technical File Reviewer within a Notified Body for active medical devices (MDD and/or MDR). - At least four years of professional experience in the healthcare product sector or related activities, including at least two years in the design, manufacture, testing, or use of the devices to be assessed or of their specific scientific aspects. - Expertise in active medical devices (e.g., monitoring devices, therapeutic devices, devices utilizing radiation, standalone software). - Good knowledge of relevant standards (e.g., EN 60601, EN 62304, EN 62366). - Strong written English skills (reports are reviewed in English). - Desirable: Knowledge of technical file codes according to the EU Commission (e.g., MDA0201–MDA0318). - Submission of an English-language resume is required. Benefits: - Work in a globally recognized, stable company and market leader in the TIC sector. - Flexible work model with remote work options. - Access to SGS University & Campus for continuous learning opportunities. - International, multicultural work environment with colleagues worldwide. - Comprehensive company benefits platform.