Ensuring that your products meet stringent safety and quality regulations and standards at both the national and international levels.Responsibilities include, but are not limited to:Quality Assurance: Develop, implement, and maintain robust Quality Management Systems (QMS) in accordance with industry standards like ISO 13485, FDA QSR and EU MDR. Conduct internal audits and assist in external audits to ensure compliance.Regulatory Affairs: Strategize and manage regulatory submissions for new product approvals, including FDA 510(k), PMA submissions, and CE Marking applications. Keep abreast of ever-changing global regulatory landscapes and interpret the impact on company products.Technical Documentation: Create and manage comprehensive technical documentation aligned with QMS and regulatory requirements. This includes device master records (DMR), technical files, risk assessments, and validation reports.Cross-functional Collaboration: Work closely with R&D, manufacturing, and other teams to ensure regulatory compliance throughout the product lifecycle, from development to post-market surveillance.Training: Provide ongoing education to various teams on regulatory requirements and quality standards, promoting a culture of quality and compliance.I have successfully led several major product submissions, resulting in market clearance in various countries. I continually work on improving systems and processes, ensuring not only compliance with but exceeding industry standards for quality and safety.

Elaborate and work independently on the certification of sync2brain as a medical-device-company and on the certification of the medical devices brought into market

Unterstützung und selbstständige Arbeit in Therapie und Forschung für die Ambulanz für transkranielle Magnetstimulation sowie das Labor für Brain- and Neuroplasticity