Product Assessor – Active Devices and SaMD


Our client a global notified body is currently seeking a Product Assessor for their active and Software as a Medical Device portfolio. Reporting to Technical Business Development Director Business the product assessor will conduct technical documentation reviews against European Medical Device Directive and Medical Device Regulation for Class I/ IIa /IIb and/or Class III within the defined timeframe. This role sits in global group and provides a fantastic career opportunity to shape and develop the role. Successful candidate must have a minimum 3 years notified body experience in a product review role The role is based can be based in US or Canada and relocation assistance can be provided



Role/Responsibilities:

• Support CE marking activities carried out by notified body including support of sales, CWS approvers or scheduling 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 policies, procedures, and processes
• Communication with team members and client with regards to the product assessment or other activities performed
• Minimise risks associated with medical device certification Key Accountabilities
• Ensure regulatory compliance of product technical documentation assessment under applicable EU Medical Devices Directives and /or Regulations
• 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 maximise 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 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 policies.

• Knowledge of European Medical Device Directive (93/42/EEC) and Regulation (EU) 2017/745 (Medical Device Regulation)
• Knowledge of key EU harmonized medical devices standards e.g. EN 14971:2019, EN 14155:2020
• Knowledge of European Medical Devices Nomenclature (EMDN)
• Medical device knowledge on MDA/MDN/MDS codes listed in Commission implementing regulation (EU) 2017/285
• Good communication techniques through electronic mediums
• Good written English skills (as reports will be reviewed/queried in English)