Regulatory Affairs Associate

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MADx – Macro Array Diagnostics GmbH

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2016

🧬 Biotecnologia

🔧 Hardware

☁️ SaaS

Biotechnology • Hardware • SaaS

A MADx – Macro Array Diagnostics GmbH é uma empresa austríaca de tecnologia médica que desenvolve e comercializa testes moleculares de imunodiagnóstico, analisadores de laboratório e software de análise baseado em nuvem para diagnósticos de alergia (IgE) e intolerância alimentar (IgG). A empresa oferece kits de teste multiplex baseados em ELISA (ALEX, FOX), instrumentos de bancada e de alto rendimento (ImageXplorer, MAX 45k) e análises em nuvem em tempo real (RAVEN/RAPTOR), enfatizando especificidade molecular, conectividade de big data e conformidade regulatória (IVDR, ISO 13485). A MADx atende laboratórios, clínicas, médicos e distribuidores em todo o mundo, posicionando-se como líder em diagnósticos moleculares de alergia.

Descrição

• 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

🎯 Requisitos

• 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).

🏖️ Benefícios

• Health insurance • Professional development opportunities