Nick Decker

WORK HISTORY

EDUCATION

ABOUT NICK DECKER

Strategically-minded professional with expansive experience leading significant global initiatives across the value chain. I am currently the Head of Regulatory Policy for Global Standards and Post market for Roche Diagnostics, the global leader in In Vitro diagnostics. I focus on shaping regulatory policy across multiple areas including global standards, cybersecurity, Preapproved Change Control Plans, among other post market policy issues. I collaborate closely with Roche Diagnostics\' translational policy team to monitor global regulatory changes to analyze the impact on the business and have led a cross-divisional effort to restructure our regulatory intelligence program including process redesign, launch of a regulatory intelligence IT solution and developing an efficient operating model for implementing new regulations.I\'ve worked for Roche Diagnostics for over a decade and prior to my current role, I led Roche Diagnostics’ EU MDR / IVDR program, guiding the organization toward industry-leading readiness for the transition to the new regulatory framework in the EU.Having led key programs Roche\'s IVDR program and developed the strategic approach for navigating the regulatory uncertainty in the UK, I have demonstrated strong capacity to deliver in the dynamic regulatory environment and in leading development and execution of regulatory policy strategies