Job 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
Requirements:
• 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).
Benefits:
• Health insurance
• Professional development opportunities