Christian P. Valcke

WORK HISTORY

EDUCATION

SKILLS

ABOUT CHRISTIAN P. VALCKE

Executive leader focusing on product lifecycle management in the medical and diagnostic healthcare industry.I have demonstrated results in commercializing novel products from concept through development and launch, including design, validation, manufacturing, clinical development and on-market support. These solutions are now helping patients in cancer diagnosis, genetics, blood donation screening, hospital acquired infections and emergency medicine.My passion is to build, lead, and empower high functioning multidisciplinary teams that bring quality products to market with tight deadlines. I establish effective interaction with partners, suppliers, and contractors. I have worked with leading third-party hardware and software companies in Japan, US, Europe, Australia, and India to scale resources and find the expertise to optimize project execution.To ensure the best value creation, I establish relations across the organization aligning the product development portfolio with business interest and maximizing rate of return. I provide input for global corporate strategy, product selection, organizational structure, evaluation of market opportunities and business development planning. With 25 years of experience in regulated products (FDA, IVD, MDD, CE, ISO), I know how to establish the processes and controls to ensure compliance, with consistent clean audit records from regulatory and corporate auditors. Agile Development | Architecture | Software Development (on/offshore)| Combination Products | Requirements | Micro-Nano fabrication | Cloud computingContact information- please message through LinkedIn