Senior Product Assessor

hace 4 días

Madrid, España Sgs Société Générale De Surveillance Sa. A tiempo completo

.Senior Product Assessor - Active Devices Full-time 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. Are you ready totake your career to the next level ? If you have a strong background as aProduct Assessor within an EUnotified body conducting MDD/MDR technical documentation review, then we have anexhilarating opportunity for you Join ourdynamic team at SGS and become aSenior Product Assessor - Active Devices . This role will allow you to make asignificant impact in the field ofcertification . Your responsibilities will include: Supporting and guiding your team of talentedProduct Assessors Conducting thorough technical documentation reviews and ensuringcompliance with EU regulations and standards. Collaborating withcross-functional teams to increaseefficiency and quality Monitoring the team'stechnical competence, KPIs, and wellbeing and providing feedback and support when there are concerns. Conductrecruitment , including reviewing CVs and undertaking interviews and supporting withonboarding of new starters Developtraining and present the training to others in SGS or externally as deemed necessary. Assist withtechnical queries and those related tosales within the Active Medical Devices field . Ensure that thehighest level of service is provided throughout the SGS network offering medical devicescertification and stakeholders throughefficient service delivery . To be eligible for this role, you should have prior experience as aProduct Assessor/Specialist/Technical File Reviewer within anotherNotified Body for active devices, conducting reviewsagainst MDD and/or MDR . Additionally, you must possess: Four years ofprofessional experience in the field ofhealthcare products or related activities, such as design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed; ActiveMedical Devices knowledge (monitoring equipment, therapeutic devices, devices utilizing radiation, stand-alone software devices, etc.) through designing, manufacturing, or testing of such devices; Thorough knowledge and understanding of relatedstandards: EN 60601, EN 62304, EN 62366, etc. ; Good writtenEnglish skills (as reports will be reviewed/queried in English); Knowledge of the followingTechnical File codes desirable (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017):MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318

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    hace 5 días

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