Product Assessor - Medical Devices (Active & Software) - MDA0303, MDA0307, MDA0315, MDA0316
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About The Position
We are currently seeking a highly skilled and detail-oriented Product Assessor (Medical Devices - Active & Software) to join our team. In this position, you will be responsible for conducting technical file reviews against the European Medical Device Directive and Medical Device Regulation for Class I/IIa/IIb and/or Class III medical devices. Your role will involve supporting CE marking activities carried out by SGS, including support of team with technical queries. Ensure that reviews are technically sound and in compliance with all applicable requirements. Support in training and qualification of colleague and create training materials. Ensure adherence to SGS policies, procedures, and processes. Communication with team members and client with regards to the product assessment or other activities performed. Minimize risks associated with medical device certification. Conduct product assessments (primarily desk-based, but occasionally may be on-site) in accordance with established procedures, maintaining a high standard of service delivery. Maintain personal competence and development in qualified specialist areas to be able to assess product technical documentation on an ongoing basis. Project manage assessments as appropriate, to maximize efficiencies, enhance client satisfaction, and ensure compliance with requirements. To assist with queries raised from product assessments. Work at all times to adhere to KPIs set as an individual and within a team. Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery. Ensure full compliance with the Company’s Code of Integrity & Professional Conduct, and act in accordance with SGS policies. At all times, adopt a safe behavior by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.
