MDR/IVDR Product Assessors (Software)
MDR/IVDR Product Assessors (Software)
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Job Description
We are looking for multiple MDR/IVDR Product Assessors with focus on Software
Product Assessor together with the Lead Auditor the Clinicians and the client is securing that the devices that we certify are efficient safe and meet the European requirements. Included in the assessment process are review of the technical documentation assessment of the compliance and reporting findings to the assessment team and to the client.
Your job description as Product Assessor would include
- Identification of the requirements standards and common specifications relevant to the devices
- Assessment of compliance based on the evidence given by the technical documentation
- Acting as an expert in MD/IVD and SW compliance topics
- Working together with our Clinicians and international associates
- Customer relations
- Process development together with the team
- Stay up to date on regulations standardization and guidance documents
- Participation in relevant seminars and trainings as well as organizing external trainings for our customers together with SGS Academy
Qualifications :
- Relevant university-level degree (for example in Technology Physics Biomedicine Chemistry Biology Cellular Biology)
- At least 4 years of work experience with medical or/and IVD devices including SW experience. Work experience can consist of quality management D&D manufacturing auditing research or testing. Experience in development of AI/ML applications is a plus.
- Knowledge of QMS standard EN ISO 13485:2016 device standards and basic legislation covering either MDR or IVDR. We do not expect you to be an expert in everything but you need to have a basic knowledge of the field.
- Preparedness and willingness to learn even with previous experience constant learning is key in this position.
- Customer service communication and co-operation skills
- Preparedness to travel sometimes mainly domestically
- Fluent English
- Please be advised that the university-level degree and relevant work experience in the MD/IVD field are legal requirements stipulated by law and are non-negotiable.
Additional Information :
SGS is a successful and stable international company where your competence is valued. Expand and enrich your career through endless opportunities to learn and fulfill your potential with an inspiring and co-operational team. We offer the chance to make a difference.
SGS offers you a friendly work community comfortable and modern workspaces in Pitjnmki office and flexible working hours. Also working partly remotely is possible.
If you are interested please apply for the position via the application link no later than August 31st 2025. Kindly also include your salary request in your application. If you have any questions about the position please reach out for MDR information: for IVDR information: mob..
#Bethechange #BeSGS
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
