Sgs: Product Assessor – Cardiovascular and Soft Tissue

remote-job.net Job Summary: 💶 Salary: not specified ⏰ Weekly hours: Full-time 🔍 Recommended experience: Senior 🎓 Recommended education: Degree in Medicine, Pharmacy, Engineering or related natural sciences 🏭 Industry: Medical technology Main tasks: Technical review of product files for cardiovascular and soft tissue products. Assessment of conformity according to MDR/MDD/UKCA for the relevant classes. Support for CE marking and communication with customers to minimize risks. ✅ Main requirements: Proven experience with cardiovascular and soft tissue devices. Knowledge in technical file review and regulatory requirements (MDR/MDD/UKCA). Degree in a relevant discipline and good English skills. About the company: SGS is the world's leading company for testing, inspection and certification (TIC). We are regarded as the global benchmark for sustainability, quality and integrity. Around 99,600 employees work in a network of approximately 2,600 offices and laboratories to enable a better, safer and more connected world. Location of this position: Madrid, Comunidad de Madrid, Spain. Responsibilities: Conduct comprehensive product assessments for cardiovascular and soft tissue products. Review technical files for compliance with MDR, MDD and UKCA for Class IIa/IIb and/or Class III. Support CE marking activities and communication with customers to mitigate risks during certification and maintenance. Contribute to the training and qualification of junior staff, including preparation of training materials. Requirements: Extensive experience with medical devices or related activities (design, manufacturing, testing, regulatory, audit or research). Specific experience with the design, manufacturing, testing or application of cardiovascular and soft tissue devices. Experience as a technical file reviewer at a Notified Body or certification body is an advantage. Degree or equivalent qualification in Medicine, Pharmacy, Engineering or related natural sciences. Good spoken and written English and strong communication skills, especially in electronic media. Knowledge of the relevant non-active MDN categories (e.g. MDN 1104, 1201, 1202, 1204, 1206, 1210, 1213, 1214). Benefits: Work in a globally recognized and stable company in the TIC sector. Flexible working model and possibility for remote work. Ongoing training opportunities via SGS University and Campus. International collaboration with colleagues from various continents. Comprehensive employee performance and benefits platform.