23 Aug REGULATORY DIRECTOR, DIGITAL MEDICINE, LONDON
We are looking for someone to join us in a Director level capacity, pioneering a new project which aims to provide medical device regulatory support for mobile medical applications for smart phones and e-tablets. This is a highly matrixed regulatory role based in London.
• Head up a already established team with a budget and mandate for building this in line with new project requirements.
• Work directly with the Medicines Development Team (MDT), the Global Regulatory Lead and the Biomarker/Diagnostics Development Leader to assess the diagnostic test needs for the companion medication and determine the strategy for the development and delivery of the diagnostic test for use in the clinical development program and for the product post-approval.
• Constructively challenge the development and current strategies, as well as the timelines being proposed for launch.
• Work with MDTs to determine a transition strategy for laboratory based tests used during the clinical development program to an in vitro diagnostic or a laboratory-developed FDA approved test at the time of drug product approval.
• Master’s Degree or PhD (or equivalent)
• Extensive experience in Software as a Medical Device and/or in vitro diagnostic (IVD) product global regulatory affairs that includes preparation/management of FDA 510(k) and Pre-Market Approval submissions and registration of medical devices and/or IVD testing products in the European Union that include compliance to EU IVDR 2017/746, EU MDR 2017/745 and ISO 13485-compliant medical device Quality Management Systems.
• Demonstrated leadership capabilities and ability to think strategically.
• Ability to integrate regulatory science with scientific/clinical knowledge
• Demonstrated track record of working in a global team and matrix organization
• Excellent negotiation skills across levels within an organisation and with external stakeholders
• Able to manage multiple projects and proactively plan
• Experience in Latin America and/or Asia Pacific medical device, medical device software and/or in vitro diagnostic test product registrations
Salary dependant on experience and negotiable upon application.
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