Senior Product Assessor

1 semana atrás

Lisboa, Portugal Sgs Tempo inteiro

Senior Product Assessor - Active Devices Lisboa Senior Product Assessor - Active Devices Lisboa Lisbon, Lisbon, Portugal Job DescriptionAre you ready to  take your career to the next level ? If you have a strong background as a  Product Assessor within an EU  notified body conducting MDD/MDR technical documentation review, then we have an  exhilarating opportunity for youJoin our  dynamic team at SGS and become a  Senior Product Assessor - Active Devices. This role will allow you to make a  significant impact in the field of  certification.As a member of our  Medical Device team , you will not only  manage a small team of globally based  Product Assessors but also  dive deep into the exciting world of  Active Medical Devices.Your responsibilities will include:Supporting and guiding your team of talented  Product AssessorsConducting thorough technical documentation reviews and ensuring  compliance with EU regulations and standards. Collaborating with - functional teams to increase  efficiency and qualityMonitoring the team's  technical competence, KPIs, and wellbeing and providing feedback and support when there are concerns.Conduct  recruitment , including reviewing CVs and undertaking interviews and supporting with  onboarding of new startersDevelop  training and present the training to others in SGS or externally as deemed necessary.Assist with  technical queries and those related to  sales within the Active Medical Devices field.Ensure that the  highest level of service is provided throughout the SGS network offering medical devices  certification and stakeholders through  efficient service delivery.QualificationsTo be eligible for this role, you should have prior experience as a  Product Assessor/Specialist/Technical File Reviewer within another  Notified Body for active devices, conducting reviews  against MDD and/or MDR.Additionally, you must possess:Four years of  professional experience in the field of  healthcare 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;Active Medical Devices knowledge (monitoring equipment, therapeutic devices, devices utilizing radiation,- alone software devices, etc. ) through designing, manufacturing, or testing of such devices;Thorough knowledge and understanding of related  standards: EN 60601, EN 62304, EN 62366, etc. ;Good written  English skills (as reports will be reviewed/queried in English); Knowledge of the following  Technical 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.#J-18808-Ljbffr

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