MADx – Macro Array Diagnostics GmbH

Sales

• Managing key accounts and acting as a point of contact for clients
• Representing MADx at conferences
• Organizing client meetings to discuss their requirements
• Timely resolving problems and handling complaints
• Identifying new potential customers; staying up-to-date with new features and product launches
• Monitoring and reporting of sales performance
• Establishing best practices and providing innovative ideas to increase sales and improve customer experience

Sales Area Manager – Southern UK

Compliance

• 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

Sales Area Manager – Southern UK

Regulatory Affairs Associate