MDSAP Technical Pack Reviewer

Main 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 Company’s Code of Integrity & Professional Conduct, and act in accordance with SGS UK’s 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 Company’s policies and procedures.