MADx – Macro Array Diagnostics GmbH · 23 hours ago
Regulatory Affairs Associate - USA
United States
Full-time
Remote
Mid, Senior Level
4+ years expMADx – Macro Array Diagnostics GmbH has revolutionized allergy diagnostics and has been operating successfully in over 90 countries for more than 9 years. They are seeking a Regulatory Affairs Associate to prepare and maintain regulatory documentation, act as a liaison with the FDA, and support regulatory strategies for the US market.
Medical
Responsibilities
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
Qualification
Required
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
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)
Preferred
Experience working with international regulatory teams and external consultants is highly desirable
Company
MADx – Macro Array Diagnostics GmbH
Since the foundation of MADx in 2016, we produce reliable allergy and food intolerance tests for diagnostic clinics, laboratories, doctors' practices and hospitals.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$4.13M2018-06-01Grant· $4.13M
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