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.br/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.br/pbJob Descriptionbr/bpbMain Purpose of Rolebr/b /pulliTo centrally manage a Lean and compliant Quality Management system for medical devices schemes (Medical includes Notified Body NB1639, UKCA, ISO 13485, MDSAP and all other Medical Schemes at SGS) /liliManagement of external audits and communication with competent authority /liliManagement of internal audits and communication with relevant departments /liliMaintaining designation under MDR/IVDR and support the development and designation under new schemes /liliMaintaining accreditation under MDSAP, ISO 13485 and UKCA and support the development of other new schemes /liliCoordinate all activities with auditing organisations ( Belgian and English competent authority, UKAS, ….) /liliCoordinate all complaints and regulatory request (CEF) to provide customers and CA appropriate answers /li /ulpThis role will report to the Head of Certification and Compliance, Business Assurance.br/ppbIt is remote based, and we are open to candidates located everywhere /bbacross Europe. But they must hold a valid work permit for their country of residency.br/b /ppbr/ppbKey Accountabilitiesbr/b /pulliOwn and oversee all medical devices processes, including the Quality Manual, Non-Conformity and CAPA handling, audits and inspections, document and records control, internal audits, quality management reviews, concessions, and impartiality. /liliSupervise the implementation and maintenance of the medical quality management system (QMS), ensuring alignment with global processes and accreditation requirements. /liliEnsure impartiality and independence from commercial interests, including conducting annual risk analyses. /liliMaintain QMS regulatory compliance to support designation and accreditation under MDR/IVDR, ISO 13485, MDSAP, and other relevant schemes. /liliLead internal and external audits and ensure timely closure of CAPAs. /liliConduct the annual Quality Management Review and ensure timely follow-up and closure of actions. /liliWrite and revise QA-related procedures and associated documentation. /liliContinuously optimise the QMS to improve turnaround times while maintaining compliance. /liliMake decisions related to the Notified Body QMS and proactively drive continuous improvement initiatives. /liliCompile and analyse data for management review reporting. /liliManage all regulatory processes to ensure full compliance across all Medical Schemes. /liliEnsure all contractual agreements, including those with inter-office and subcontractors, are current, compliant, and properly maintained. /liliResponsible for updating the Quality Management System (QMS) and informing relevant medical personnel in response to changes in standardisation activities, applicable legislation, guidance, and best practices. /liliPlanand implement relevant regulatory training programs in collaboration with training team. /liliEnsure the SGS Medical website remains current and accurate in terms of regulatory content. /liliBuild strong working relationships with global medical device teams and proactively work on projects with stakeholders /liliProvide technical support and training across the business, when required /liliManage and develop the Quality regulatory team, including performance management, coaching, and staff development. /li /ulpbr/ppbSkills Knowledgebr/b /ppEssentialbr/pulliStrong knowledge of Medical Device Regulations (MDD, MDR, IVDR) and ISO13485, ISO17021 and MDSAP /liliStrong ability to work with senior management, technical, marketing, sales, and administrative personnel at a corporate, regional and delivering office level /liliAbility to represent SGS to medical device regulatory authorities and other external fora /liliExcellent interpersonal and communication skills including fluency in English /liliNegotiation and persuasion skills /liliChange Management skills /liliStrong organisational skills and flexibilty /lilib5+ years’ experience in Quality Assurance or Regulatory assurance on a global or multi-site scale gained in a Notified Body organization (a must have). /b /lili2+ year experience in team management (must have) /liliHas at least 10 years’ experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories or Industry /liliHas a keen eye for detail and is focussed on delivering results within agreed timeframes /liliOperates ethically with the highest degree of professional integritybr/li /ulbQualificationsbr/bpEssentialbr/pulliHigher education qualification (Masters / Ph.D. / B.Sc. (Hons) Degree) in a relevant life / natural sciences subject. /liliCompleted Medical device training on MDD, MDR, IVDR, UKCA, MDSAP and ISO 13485 /li /ulpbPlease send your CV in Englishbr/b /pbAdditional Informationbr/bpbWhy SGS?br/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