GRA Product Business support

Title: GRA Product Business support

Location:
Remote (Preferred NJ not mandate)

Duration: 11 months

The 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 the

GRA key contacts for the specific area. The major topics concerned are:
Combination Products
In-vitro-diagnostics (including Companion diagnostic development and Biomarkers in clinical trials)
Administration, dispensing and delivery devices
Medical Device Software (highly divers medical purposes and application cases)
Borderline & Classification questions

Expertise of Role
The vendor staff requires strong global expertise in both regulatory:
" Medical Devices and In-vitro-Diagnostics framework
" CMC and clinical drug development projects
The 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 CDx
3. Familiar with the harmonization efforts according IMDRF and former GHTF
4. Bridging of regulatory MD and IVD files to other regions, for marketed products but also in context of Biomarkers in clinical drug trials
5. International handling of integral and non-integral Drug-Device-Combinations
6. Understanding of impact and options in management of MDs and IVDs in global clinical trials
7. Determination and Classification of Medical Devices and In-vitro diagnostics
8. Experience in global CDx development and complementary diagnostics
9. Familiar with international Dossier Requirements
10. Experience in analytical, technical and clinical validation of MDs and IVDs
11. Familiar with Medical Device Software development and related requirements concerning Software validation and Cybersecurity
12. Familiar with international UDI and Medical Device Dossier requirements

Diverse 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.