Isen, Bavaria, Germany
Regulatory Affairs and Quality Manager with several years of professional experience. Offering an accurate and thorough work approach with excellent skills in recognizing what's important. Meritocratic team player with a strategic vision and great attention to detail. My current and past area of responsibility includes among other things: • Guiding cross-functional teams on regulatory requirements • Performing strategic regulatory planning of product registrations on a global scale • Providing regulatory support of development projects • Participating in internal and external audits as a front/backroom manager • Acting as "Person Responsible for Regulatory Compliance" [PRRC] If you are interested in professional exchange, please do not hesitate to contact me directly. I look forward to establishing new contacts and to hearing from you!
• Lead, develop, and manage a five-person Regulatory Affairs team for medical software, including personnel development and compensation decisions. • Own and continuously improve regulatory procedures and processes across the QMS. • Develop and implement regulatory strategies for SaMD, AI/ML-based, and cloud-connected medical devices (EU MDR, FDA, IEC 62304). • Serve as Front Room and Back Room Manager during external certification audits and regulatory inspections (TÜV Süd, FDA). • Represent Brainlab in the IEC 62304 Working Group (DKE/IEC), contributing to international standard revisions. • Lead internal audit program as Internal Lead Auditor, including auditor training and team coordination. • Create, review, and release technical documentation and marketing materials in line with regulatory requirements. Achievements • Spearheaded company-wide EU AI Act implementation into the QMS, delivering all milestones on schedule. • Supported FDA inspection in the role of Back Room Manager, achieving zero findings, and successfully accompanied all external certification and customer audits. • Contributed to the advancement of the internal AI/ML development process based on FDA feedback and new regulatory requirements.
• Concentrate on product submissions (e.g., FDA 510(k) or CE marking) and development of regulatory strategies, along with technical documentation (e.g., STED or EU MDR) and risk management according to ISO 14971. • Engage in a number of technical objectives, including software development according to EN 62304 and EN 82304-1, artificial intelligence (AI), machine learning (ML), Software as a Medical Device (SaMD), Software as a Service (SaaS), and cloud and mobile devices. • Optimize processes and interfaces across the Quality Management System (QMS). • Fulfill document and record control using Good Documentation Practice. • Conduct internal and external audits such as EU MDR, MDSAP, or FDA inspections featuring a front room/back room setup. • Execute supplier audits and management duties. • Take corrective and preventive actions (CAPA). • Contribute to QMS and product remediation, as well as (SW) tool and process validation. • Oversee administration of complaint handling and vigilance, field actions and recalls, and non-conformities. • Function as a Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC). • Deliver project support and planning solutions. • Enact standards management and related duties.
• Provide leadership, own processes, and oversee functions of the RA team. • Function as Person Responsible for Regulatory Compliance (PRRC), and acting as the proxy for the Head of QM/RA and QMR (QMB). • Facilitate development projects by providing regulatory guidance during all design control phases of the product lifecycle. • Accountable for coordinating, monitoring, and submitting regulatory submissions such as US FDA 510(k)s or Technical Documentation acc. EU MDR. • Direct operations for both the back and front office during audits and inspections. • Host training opportunities for colleagues on regulatory requirements and internal procedures. • Supervise, review, and implement regulatory requirements on a global scale. • Administer and support cross-functional teams in other areas like CAPA, Risk Management, Complaint Handling, Vigilance/MDR, Field Actions and Recalls, Clinical Evaluation and Investigation, and Post-Market Surveillance. • Introduce new software tools and solutions that improve current systems. • Participate in and support software validation efforts. Achievements • Responsible for remediating and restructuring the RA department and significantly improving internal and external audit results. • Synchronized and consolidated local processes with corporate QMS. • Attained EU MDR certification ahead of project plan.
• Governed and took responsibility for the QM team (including CAPA, complaint management, MDR and vigilance, KPI reporting, internal/external audits, and document control), along with acting as the proxy for Head of QM/RA and QMR (QMB). • Managed both back and front office during audits and inspections. • Educated colleagues on regulatory requirements and internal procedures. • Ascertained timely KPI reporting, both internally and on the corporate level. • Monitored and implemented corporate guidelines and procedures, as well as EU MDR requirements. • Spearheaded process optimization work groups. • Introduced new software tools that resulted in improvements to current systems. • Performed and supported software validation objectives. Achievements • Minimized open complaints via process optimization. • Revitalized the document control process while concurrently improving efficiency and acceptability. • Ensured MDSAP compliance and readiness. • Devised a US-focused regulatory strategy for the product portfolio, reducing lead time and risks, as well as successfully submitting three 510(k) submissions. • Performed change of notified body.