GRA Product Business support for Medical Devices--Parkway, NJ(Remote)

Below are keywords for reference
Pharmaceutical company and working on medical devices
Combination products

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 scopeExpert 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

More detailed description:
For this role, it is mandatory to engage in proactive collaboration with the regulatory business functions on product handling and thoroughly investigate potential critical issues to provide related assessments/inputs. The vendor must actively contribute to individual development projects and the overall portfolio to clarify MDR/IVDR requirements and translate this to the clinical trial-and regulatory product teams. Staff must recognize key differences in terminology, collaboration, and risk management responsibilities to navigate tasks effectively.

Specific individual tasks:
Regulatory review of documentation packages for submission of Clinical Investigations (CI)/Clinical Performance Studies (CPS), Technical Files, Medical Devices Dossiers and Notified Body Opinion Dossiers
Provide regulatory consultancy services concerning MD/IVD topics to the different GRA stakeholders in various scenarios from development throughout the product life cycle
Experience with EMA consultation procedure for CDx Approvals
Able to advise on the right interaction partner concerning scientific advice and other official interactions (e.g. for Europe: EMA, NCA (drug), NCA (devices), NB ) in context of:
Devices and IVDs used in clinical trials
Combined studies
Studies for CDx development
CE marking procedures
NBOp and other procedure in other regions and countries concerning Combination Products
CDx approvals and life-cycle-management activities of MDs and IVDs

CAPA management
Feeding insights from daily activities into the Capability function and adapting to outputs from Capability-related tasks. Educational mindset to promote understanding of risk management principles per ISO 14971
Making proposals for trial design adaptations for effective handling of MDs and IVDs in clinical trials according risk management approaches as stipulated by ICH E6(R3) (version 6, Jan 2025).
Service Scope of Role
This role profile is dedicated to the regulatory handling of Medical Devices and In-vitro diagnostics in individual life cycle and development activities of pharmaceuticals within Client.