Mdr/ivdr Product Assessors (software)

MDR/IVDR Product Assessors (Software)

SGS is the world's leading Testing, Inspection and Certification company. We operate a network of over 2,600 laboratories and business facilities across 115 countries, supported by a team of 99,600 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.

SGS Fimko Ltd. employs about 240 experts in Finland. Our headquarter is in Helsinki, but we have sites also in Espoo, Tuusula, Kotka, Tampere and Rauma.

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 Pitäjänmäki 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: seppo.vahasalo@sgs.com, mob. +358 40 560 9500 and for IVDR information: mari.levula@sgs.com, mob. +358 44 744 1308.

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