GRA Product Business support

Title: GRA Product Business supportLocation: Remote (Preferred NJ not mandate)Duration: 11 monthsThe service scope includes the enabling of translating drug development requirements into the consequences in the medical device framework and vice versa under consideration of the Client's company positions.Objectives and scope Expert consulting and support activities for MDs, Integral DDCPs, and IVDs throughout product development and maintenance. This includes Business support (reporting, documentation, strategy development, ad-hoc requests, etc.) for GRSLs, GRL CMCs, RA Regions, and GRO, as well as direct interactions with the development teams on every level, in alignment with theGRA key contacts for the specific area. The major topics concerned are:Combination ProductsIn-vitro-diagnostics (including Companion diagnostic development and Biomarkers in clinical trials)Administration, dispensing and delivery devicesMedical Device Software (highly divers medical purposes and application cases)Borderline & Classification questionsExpertise of RoleThe vendor staff requires strong global expertise in both regulatory: Medical Devices and In-vitro-Diagnostics framework CMC and clinical drug development projectsThe vendor shall demonstrate profound expertise and prepare decisions in the following specific areas:1. In depth knowledge of the medical device system EU and US with particular focus on Combination products, software and Companion Diagnostic (CDx)2. Understanding in regulatory management of medical devices in China and Japan and further countries with particular focus on Combination products, software and CDx3. Familiar with the harmonization efforts according IMDRF and former GHTF4. Bridging of regulatory MD and IVD files to other regions, for marketed products but also in context of Biomarkers in clinical drug trials5. International handling of integral and non-integral Drug-Device-Combinations6. Understanding of impact and options in management of MDs and IVDs in global clinical trials7. Determination and Classification of Medical Devices and In-vitro diagnostics8. Experience in global CDx development and complementary diagnostics9. Familiar with international Dossier Requirements10. Experience in analytical, technical and clinical validation of MDs and IVDs11. Familiar with Medical Device Software development and related requirements concerning Software validation and Cybersecurity12. Familiar with international UDI and Medical Device Dossier requirementsDiverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company. Experience: 3 years required