PpWe 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. /ppAt 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. /ph3Job Description /h3pbMain Purpose of Role /b /pulliLeading and coordinating the operational delivery of all medical schemes including MDR and IVDR conformity assessment activities under SGS NB 1639. /liliThis role ensures the effective performance of clinical, audits, technical, and product assessment functions, driving operational excellence, regulatory compliance, and strategic resource management. /liliOversees all technical teams, manages performance, and supports the development of processes, systems, and personnel to meet business and regulatory objectives. /li /ulpThe role reports to thebHead of Notified Body 1639. /b /ppbKey Accountabilities /b /ppThe role encompasses a wide range of responsibilities, including but not limited to the following: /pulliLead and manage technical functions: clinical, auditors, products assessors, for all medical schemes, globally. /liliEnsure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements throughout assessment lifecycles. /liliEnsure the team follows efficient allocation and utilization of technical resources across all conformity assessment activities (in coordination with Commercial Delivery). /liliOperational management of technical certification activities, including resource allocation, technical KPI monitoring, and process improvements. /liliLead training and competence management strategies across technical teams to maintain regulatory and technical expertise. /liliSupport proactive recruitment, onboarding, and qualification of personnel involved in conformity assessment. /liliDrive continuous improvement of technical workflows, IT systems supporting assessment, and quality management processes to enhance efficiency and service quality. /liliAct as key interface with regulatory authorities, accreditation bodies, and internal stakeholders to maintain SGS reputation, designations, accreditations and compliance. /liliMonitor and respond to regulatory changes, industry trends, and accreditation requirements to ensure proactive adaptation of technical operations. /liliManage and promote impartiality and conflict of interest policies across all teams (including subcontractors), ensuring independence of conformity assessment decisions. /liliEnsure compliance with SGS integrity policies, health safety standards, and confidentiality across technical operations. /liliFoster a culture of client focus, integrity, and continuous development within technical teams (while maintaining impartiality and regulatory rigor). /liliCollaborate with Commercial Delivery to harmonize handovers (contract→planning→assessment), align capacity with demand, and support timely service without compromising compliance. /liliProvide strategic input into designation maintenance and regulatory engagement, coordinating technical evidence, metrics, and remediation plans as required. /liliCommercial/Delivery Touchpoints carried over for completeness (scoped to technical dependencies): /liliProvide technical input to commercial business development and bid responses when needed (e.g., feasibility, scope, technical risk, assessor profiles). /liliSupport budget/KPI visibility for technical operations and contribute to overall performance management. /li /ulpbSkills Knowledge /b /pulliStrong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO13485 and MDD. /liliProven and solid leadership in managing cross-functional teams in regulated environments. /liliKnowledge of conformity assessment procedures and QMS requirements. /liliExcellent interpersonal and stakeholder management skills. /liliStrong organizational and change management capabilities. /liliStrong commercial understanding and appreciation of the TIC industry. /liliExperience in resource planning. /liliQualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR. /liliQualification as Final Reviewer and Decision Maker under MDR or IVDR. /liliExperience in a Notified Body or equivalent regulatory organization. /li /ulpbExperience /b /pulliMinimum 10 years in the medical device or IVD industry, including experience in design, manufacturing, auditing, or technical documentation assessment. /liliAt least 5 years senior leadership in a Notified Body managing technical employees. /liliMinimum 2 years in revenue-focused leadership roles, including full profit and loss (PL) accountability, budget management, and financial reporting. /liliDemonstrated success in PL role. /liliDemonstrated success in leading high-performing teams and driving operational efficiency, with a track record of delivering measurable, positive organizational impact. /liliFluency in English in addition to the local language. /liliGiven the complex network internal interactions of this role, experience gained within the SGS Group would be an advantage. /li /ulpbQualifications /b /pulliUniversity degree in medicine, engineering, life sciences, or a related field. /li /ulpThe role can be fully remote and we are open to consider candidates located accros Europe (with valid work permit). Please kindly write your CV in English /ph3Additional Information /h3pbWhy SGS? /b /pulliGlobal and very stable company, world leader in the TIC (Testing, Inspection and Certification) industry. /liliFlexible schedule and hybrid model. /liliSGS university and Campus for continuos learning options. /liliMultinational environment where you will work with colleagues from multiple continents. /liliBenefits platform. /li /ulpbJoin Us: /bAt 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