Job Title

We 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.At 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.Job DescriptionMain Purpose of RoleTo conduct reviews of MDSAP reports and approve or raise queries based on technical and procedural knowledgeEnsure that reviews are technically sound and in compliance with all applicable regulations, standards, guidelines and Competent Authority expectationsEnsure that the highest level of service is provided through efficient service delivery and that customer requirements are metEnsure adherence to SGS Policies, procedures and processesAs a member of the Global Medical Device office (MDO) to minimise risks associated with medical device certification.Key AccountabilitiesMaintain up-to-date understanding of MDSAP requirement, including all jurisdiction requirements, regulatory transmittals, MDSAP Audit Approach manual, and all associated standardsMaintain up-to-date understanding of the MDSAP grading system, corrective and preventive action, and use of the NGE formReview MDSAP audit packs according to specified requirementsGenerate Query Sheets for any noted deficiencies in the MDSAP audit packReview and accept/reject query correctionsSubmit final approved documents to the Global MDSAP administrator for submission to REPSSubmit final approved document to the SGS system and approve the MDSAP packApprove MDSAP certificates after technical approval.Participate in team meetingsMaintain on-time reviews based on Regulatory requirementsParticipate in achievement of KPIsDetermine final approval for MDSAP audit packages and the issue of MDSAP certificatesSignature authority for final MDSAP reports and NGEIf approved as an AO submitter, make submissions to REPS as requiredEnsure full compliance with the Companys Code of Integrity & Professional Conduct, and act in accordance with SGS UKs Equality & Diversity Policy and ensure others do so.At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Companys policies and procedures.QualificationsSkills & KnowledgeEssentialMedical device knowledge/codesGood communication techniques through electronic mediumsGood written English skills (as reports will be reviewed/queried in English) Thorough understand of risk management systems and requirementsCustomer FocusTeamworkDesirableExperience of working to KPIsExperience of planning own workload/prioritiesAbility to work with online systemsExperienceEssentialFour years professional experience in the field of Medical Devices or related activities, (Advanced degrees can substitute for a maximum of three years of working experience)In exceptional cases, a demonstration of equivalent knowledge and skills may be acceptable.Previous MDSAP Lead Auditor ExperienceDesirableExperience as Medical Device audit Technical ReviewerPrevious experience working for regulatory jurisdictions or with regulatory requirements of any MDSAP Member country.QualificationsEssentialSuccessful completion of a university or technical college degree or equivalent qualification in relevant studies e.g. medicine, science, pharmacy, engineering or other relevant sciencesMDSAP Lead Auditor QualificationDesirableAdvanced degrees in engineering, science, or other relevant areasAdditional InformationWhy SGS?Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.Enjoy a flexible schedule and work model.Access SGS University and Campus for continuous learning options.Thrive in a multinational environment, collaborating with colleagues from multiple continents.Benefit from our comprehensive benefits platform.Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.