MADx – Macro Array Diagnostics GmbH · 8 hours ago
Regulatory Affairs Associate - USA
Washington, DC
Full-time
Onsite
Mid, Senior Level
4+ years expMADx – Macro Array Diagnostics GmbH is a company that has revolutionized allergy diagnostics with its innovative products and patented technologies, successfully operating in over 90 countries. They are seeking a Regulatory Affairs Associate to prepare and maintain regulatory documentation, act as a liaison with the FDA, and support regulatory strategy 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
Company data provided by crunchbase