Product/Technical Assesor Medical Devices (H/M/D) REMOTE

Sobre nuestros clientes

You will be part of an important company with a global reference in quality.

Descripción de la oferta

As a member of our Medical Device team, you will not only manage a small team of globally based Product Assessors but also dive deep into the exciting world of Active Medical Devices.

• Conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards.
• Collaborating with cross-functional teams to increase efficiency and quality
• Perform training and present the training to others in company or externally as deemed necessary.
• Assist with technical queries and those related to sales within the Active Medical Devices field.

Perfil buscado

Be a professional with a lot of passion!

• You should have prior experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for active devices, conducting reviews against MDD and/or MDR.
• Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
• Active Medical Devices knowledge (monitoring equipment, therapeutic devices, devices utilizing radiation, stand-alone software devices, etc.) through designing, manufacturing, or testing of such devices; Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc.
• Good written English skills (as reports will be reviewed/queried in English); Knowledge of the following Technical File codes desirable (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318.

• Fluent professional English, essential requirement (C1).

Qué ofrecemos

• Immediate incorporation
• Permanent position in a World reference company
• Continuous training by the company
• Attractive fixed + variable salary