Ph3Company Description /h3 pWe are SGS – the world's leading testing, inspection and certification company. We are 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. /p h3Company Culture Values /h3 pAt SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future‑oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety Environment, Quality Professionalism, Respect, Sustainability, and Leadership. /p h3Job Description /h3 h3Main Purpose of Role /h3 ul liLeading and coordinating the operational delivery of all medical schemes including MDR and IVDR conformity assessment activities under SGS NB 1639. /li liThis role ensures the effective performance of clinical, audits, technical, and product assessment functions, driving operational excellence, regulatory compliance, and strategic resource management. /li liOversees all technical teams, manages performance, and supports the development of processes, systems, and personnel to meet business and regulatory objectives. /li /ul pThe role reports to the bHead of Notified Body 1639. /b /p h3Key Accountabilities /h3 ul liLead and manage technical functions: clinical, auditors, products assessors, for all medical schemes, globally. /li liEnsure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements throughout assessment lifecycles. /li liEnsure the team follows efficient allocation and utilization of technical resources across all conformity assessment activities (in coordination with Commercial Delivery). /li liOperational management of technical certification activities, including resource allocation, technical KPI monitoring, and process improvements. /li liLead training and competence management strategies across technical teams to maintain regulatory and technical expertise. /li liSupport proactive recruitment, onboarding, and qualification of personnel involved in conformity assessment. /li liDrive continuous improvement of technical workflows, IT systems supporting assessment, and quality management processes to enhance efficiency and service quality. /li liAct as key interface with regulatory authorities, accreditation bodies, and internal stakeholders to maintain SGS reputation, designations, accreditations and compliance. /li liMonitor and respond to regulatory changes, industry trends, and accreditation requirements to ensure proactive adaptation of technical operations. /li liManage and promote impartiality and conflict of interest policies across all teams (including subcontractors), ensuring independence of conformity assessment decisions. /li liEnsure compliance with SGS integrity policies, health safety standards, and confidentiality across technical operations. /li liFoster a culture of client focus, integrity, and continuous development within technical teams (while maintaining impartiality and regulatory rigor). /li liCollaborate with Commercial Delivery to harmonize handovers (contract→planning→assessment), align capacity with demand, and support timely service without compromising compliance. /li liProvide strategic input into designation maintenance and regulatory engagement, coordinating technical evidence, metrics, and remediation plans as required. /li liCommercial/Delivery Touchpoints carried over for completeness (scoped to technical dependencies): /li liProvide technical input to commercial business development and bid responses when needed (e.g., feasibility, scope, technical risk, assessor profiles). /li liSupport budget/KPI visibility for technical operations and contribute to overall performance management. /li /ul h3Skills Knowledge /h3 ul liStrong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO13485 and MDD. /li liProven and solid leadership in managing cross‑functional teams in regulated environments. /li liKnowledge of conformity assessment procedures and QMS requirements. /li liExcellent interpersonal and stakeholder management skills. /li liStrong organizational and change management capabilities. /li liStrong commercial understanding and appreciation of the TIC industry. /li liExperience in resource planning. /li liQualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR. /li liQualification as Final Reviewer and Decision Maker under MDR or IVDR. /li liExperience in a Notified Body or equivalent regulatory organization. /li /ul h3Experience /h3 ul liMinimum 10 years in the medical device or IVD industry, including experience in design, manufacturing, auditing, or technical documentation assessment. /li liAt least 5 years senior leadership in a Notified Body managing technical employees. /li liMinimum 2 years in revenue‑focused leadership roles, including full profit and loss (PL) accountability, budget management, and financial reporting. /li liDemonstrated success in PL role. /li liDemonstrated success in leading high‑performing teams and driving operational efficiency, with a track record of delivering measurable, positive organizational impact. /li liFluency in English in addition to the local language. /li /ul h3Desirable /h3 ul liGiven the complex network internal interactions of this role, experience gained within the SGS Group would be an advantage. /li /ul h3Qualifications /h3 ul liUniversity degree in medicine, engineering, life sciences, or a related field. /li /ul h3Remote Work /h3 pThe role can be fully remote and we are open to consider candidates located across Europe (with valid work permit). Please kindly write your CV in English. /p h3Additional Information /h3 h3Why SGS? /h3 ul liGlobal and very stable company, world leader in the TIC (Testing, Inspection and Certification) industry. /li liFlexible schedule and hybrid model. /li liSGS university and Campus for continuous learning options. /li liMultinational environment where you will work with colleagues from multiple continents. /li liBenefits platform. /li /ul h3Join Us /h3 pAt SGS we believe in innovation, collaboration, and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development. /p /p #J-18808-Ljbffr