Product Reviewer - SaMD

Over de functie

As a Technical Documentation Reviewer, you play an essential role in assessing the safety, performance and compliance of innovative medical devices according to the MDR. Kiwa has a focus on Software as a Medical Device (SaMD) and AI-enabled technologies for innovative SME’s. Your expertise contributes directly to bring safe and innovative devices to the patient.

In this position, you independently perform technical documentation assessments and support certification process. Kiwa supports a hybrid working environment, after your start-up period, you will work one day per week from our office in Woerden, while the remaining days can be performed from home. You will occasionally travel within Europe for unannounced audits as a technical expert. Regular audits are performed by our lead auditors (other role).

Key Responsibilities:

• Review SaMD and AI documentation including Regulation (EU) 2024/1689;
• Perform end-product verification and review PMS/ PSUR’s results;
• Keep your knowledge up-to-date and share with your colleagues during the monthly knowledge sharing sessions;
• Guide trainee and junior reviewers;
• Final review of certification activities (based on experience).

Wat verwachten wij van jou?

You are an experienced reviewer with strong analytical skills.

Requirements:

• Completed degree in engineering, medicine, computer science or similar;
• 3+ years technical file review experience at a Notified Body;
• SaMD experience and MDA 0315 competence;
• Knowledge of lifecycle processes and ML principles;
• Fluent in English;
• You are living in the Netherlands.

Wat zetten wij daar tegenover?

• “Enjoy your work as part of an enthusiastic and highly motivated team.
• 30 days paid leave;
• Secondary benefits including lease bike and pension;
• Laptop, phone and necessary tools;
• Training and education opportunities.

About Kiwa

Kiwa is a global leader in TIC services with a mission to improve safety, quality and sustainability.

Team Description

You will join a supportive and improvement minded, team with high expertise and different nationalities. We stay close to our SME customers while keeping our impartiality and independency.