Regulatory Affairs Associate

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MADx – Macro Array Diagnostics GmbH

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2016

🧬 Biotechnologie

🔧 Matériel

☁️ SaaS

Biotechnology • Hardware • SaaS

MADx – Macro Array Diagnostics GmbH est une entreprise autrichienne de technologies médicales qui développe et commercialise des tests moléculaires d'immunodiagnostic, des analyseurs de laboratoire et des logiciels d'analyse basés sur le cloud pour le diagnostic des allergies (IgE) et des intolérances alimentaires (IgG). L'entreprise propose des kits de test multiplexés basés sur ELISA (ALEX, FOX), des instruments de laboratoire sur paillasse et à haut débit (ImageXplorer, MAX 45k) ainsi que des analyses cloud en temps réel (RAVEN/RAPTOR), mettant l'accent sur la spécificité moléculaire, la connectivité avec les big-data et la conformité réglementaire (IVDR, ISO 13485). MADx sert des laboratoires, cliniques, médecins et distributeurs à travers le monde, se positionnant comme un leader dans le diagnostic moléculaire des allergies.

Description

• Preparing, maintaining, reviewing, and updating regulatory and technical documentation to support FDA submissions, including Pre-Submissions (Q-Subs) and preparation, coordination, and participation in FDA meetings • Acting as a primary regulatory interface for communication with the FDA, including drafting, coordinating, and submitting responses to FDA inquiries within defined timelines • Preparing and supporting activities required for FDA clearance, approval, and ongoing compliance, including 510(k), DeNovo, and PMA submissions, as applicable • Supporting the development, implementation, and continuous optimization of the regulatory strategy for the US/FDA market • Working closely with the Regulatory Affairs team in Vienna to ensure alignment between US and global regulatory activities • Coordinating regulatory activities with our US-based regulatory consultant and internal cross-functional stakeholders • Ensuring a thorough understanding and correct interpretation of FDA regulations applicable to in vitro diagnostic medical devices, with a strong focus on multiplex tests • Supporting internal and external audits, FDA inspections, and regulatory reviews, including preparation of documentation, follow-up actions, and responses • Contributing to post-market surveillance, change management, and life-cycle activities, as well as the preparation and maintenance of SOPs, work instructions, and templates, where relevant

🎯 Exigences

• Degree in medical technology, biology, biochemistry, or a comparable scientific discipline • 4 - 7 years of experience in Regulatory Affairs for medical devices and/or in-vitro diagnostics • Solid experience with FDA regulations and submission pathways (e.g. Pre-Sub (Q-Sub), 510(k), De Novo, PMA, depending on product classification and regulatory strategy) • Strong understanding of FDA requirements for multiplex and molecular diagnostic tests, including analytical and clinical performance expectations • Experience working with international regulatory teams and external consultants is highly desirable • Structured, detail-oriented working style with the ability to work independently as well as collaboratively in a cross-functional environment • Strong written and verbal communication skills, with a proactive, solution-oriented mindset • Excellent command of English (written and spoken).

🏖️ Avantages

• Health insurance • Professional development opportunities