Sgs: Product Assessor – Soft Tissue Team
Job summary: Salary: not specified Weekly working hours: Full-time Recommended experience: Senior Recommended education: Degree (e.g., Bachelor) in Medicine, Pharmacy, Engineering or related natural sciences Industry: Healthcare Main responsibilities: Technical assessment of cardiovascular and soft tissue products. Review of technical files in accordance with MDR/MDD/UKCA. Support for CE marking and training of junior staff. Key requirements: Practical experience with cardiovascular and soft tissue devices. Knowledge of MDR/MDD/UKCA and technical file assessment. Very good English skills and communication ability. About the company: SGS is the world-leading company for testing, inspection and certification (TIC). We are regarded as a global benchmark for sustainability, quality and integrity. Our 99,600 employees work in a network of 2,600 offices and laboratories and pursue the goal of enabling a safer and more connected world. Headquarters: Madrid, Comunidad de Madrid, Spain. Responsibilities: Carry out comprehensive product assessments for cardiovascular and soft tissue products. Review technical files for compliance with MDR, MDD and UKCA (classes IIa/IIb and/or III). Support CE marking activities and minimise risks during certification. Contribute to the training and qualification of junior staff and the development of training materials. Communicate effectively with the team and clients regarding product assessments and certification matters. Requirements (detailed): Extensive experience with medical devices or related activities (design, manufacture, testing, regulatory, audit or research). Specific experience with the design, manufacture, testing or use of cardiovascular and soft tissue devices. Advantageous: experience as a Technical File Reviewer at a Notified Body/certification body. Degree or equivalent qualification in Medicine, Pharmacy, Engineering or related natural sciences. Strong communication skills, especially electronically; very good English skills, spoken and written. Knowledge of the relevant MDN categories for non-active soft tissue and non-active non-implantable devices (per Regulation 2017/2185). Benefits: Work for a globally recognised, stable company in the TIC sector. Flexible working hours and a remote working model. Continuous learning opportunities via the SGS University and Campus. International collaboration with colleagues worldwide. Comprehensive benefits platform.