Regulatory Affairs Associate

Join the MADx Revolution. We have revolutionized allergy diagnostics and have been operating successfully in more than 90 countries for over 9 years with our diagnostic products and patented technologies. Our products help clarify allergies in a single step – for humans and animals alike. Allergies are diagnosed with high specificity, enabling patients to receive help from their specialists in no time. We improve quality of life, enable personalized treatment, advance research, and relieve the burden on our healthcare system.

Key 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.

Your Profile:

• 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).