MDR/IVDR Product Assessor (Software) - Remote

Overview

We are looking for multiple MDR/IVDR Product Assessors with a focus on Software to ensure that the devices we certify are efficient, safe, and meet European requirements.

In Short

• Identify requirements, standards, and specifications relevant to devices.
• Assess compliance based on technical documentation.
• Act as an expert in MD/IVD and SW compliance topics.
• Collaborate with Clinicians and international associates.
• Manage customer relations.
• Develop processes with the team.
• Stay updated on regulations and guidance documents.
• Participate in seminars and organize trainings.

Requirements

• Relevant university-level degree (Technology, Physics, Biomedicine, etc.).
• At least 4 years of experience with medical/IVD devices, including SW experience.
• Knowledge of QMS standard EN ISO 13485:2016 and device standards.
• Willingness to learn and adapt.
• Strong customer service and communication skills.
• Preparedness to travel domestically.
• Fluent in English.
• Legal requirements for degree and experience in MD/IVD field.

Benefits

• Valued competence in a stable international company.
• Opportunities for continuous learning and career development.
• Friendly work community and modern workspaces.
• Flexible working hours and remote work options available.