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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Notified Body Product Assessor -Active Devices


Reference:JCAO1810 Location: Canada
Outside EU
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs Executive, Research and Development Engineer

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.
Skills & Experience
  • 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)


For further information please contact James Cassidy [email protected] or call in confidence +353 86 0204322