Senior Product Assessor - Active Devices > SGS > Joboolo BE :
Société : SGS Lieu : Antwerp Flanders Site source : Talent BE
Your responsibilities will include:
Supporting and guiding your team of talented ProductAssessorsConducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards. Collaborating with cross-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 ProductAssessor/Specialist/Technical File Reviewer within another Notified Body for activedevices, 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, stand-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):
