Leuven, Flemish Region, Belgium
Committed to meet project and strategic business objectives. Fostering positive teamwork in a cross-functional and global environment, while keeping the customer-centric solutions focus. Establishing and implementing global regulatory strategies. Managing multiple projects and continuous improvement programs in boundary-crossing healthcare contexts (CDx). Problem-solving change agent embracing and driving business processes and organizational transformation to increase performance and customer satisfaction. Team player and coach, inspiring colleagues and encouraging creative thinking. Fostering collaborative relationships with strategic partners and regulatory authorities. Enthusiastic business manager with rich experience in supply chain operations and service design.
- Global Pre- and Postmarket Authorizations Applications (MAAs) - Principal markets: EU; UK; MDSAP countries; US - Molecular and CDx IVD Medical Devices in Oncology and Infectious Disease (IVDR Class C & D)
Expand and maintain Biocartis global IVD product market access by establishing and implementing regulatory strategies, streamlining the functional area operations with corporate business objectives. Show regulatory leadership and provide RA expert input to cross-functional teams involved with IVD/CDx development planning to positively influence project planning and decision making, market authorization, and time-to-market. Oversee the regulatory budget, including on-market surveillance and vigilance activities. Conduct regulatory intelligence research; prepare and submit registration files to national regulatory authorities.
- Designed, implemented and validated customer-first service processes; monitored customer satisfaction; - Managed supply chain, forecasting, and procurement operations; evaluated supplier performance; - Project managed inter-company continuous improvement programmes; - Established performance-driven strategic partnerships with ICT service providers to streamline business processes; established collaborative strategic partnerships; - Analyzed large databases supporting decision-making processes to increase performance and revenues. - Managed marketing and communications, social media, SEO writing.
Regulatory management and company compliance; privacy and GDPR program management; risk management, internal control, and CAPA remediation.
Established a successful, customer-centric cluster pharmacy and wound care business from the ground up, strategically and innovatively growing the company, drove supply chain and continuous improvement programmes, developed a cohesive patient-focused team, built effective partnerships. Founder of Medstore.be, online pharmacy.
Designed a global and local service process strategy for Biocartis' Idylla system.
- Project management of molecular diagnostics system and product development Cross-functional team lead; project and risk management; design control and transfer; strategic partnership management; control quality and compliance (CE/IVD). - Manufacturing Manager Operations Management molecular diagnostics; project managed CE/IVD/FDA quality compliance programme; performed quality audits, validated processes and equipment.