Medical Device Industry
Rate: BR to BR
Location: US
Remote/hybrid Flexibility onsite needed: Remote

Below are keywords for reference

Pharmaceutical company and working on medical devices
Combination products


Support in Capability Management concerning Medical Devices & Diagnostics
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
This part is related to monitoring the changes in the global regulatory environment, initiation of business process improvement-, adoption and organizational change management within GRA and the interfaces of other business functions with GRA concerning IVDs and MDs. We seek a partner to develop a sustainable concept for MD/IVD Governance from early development throughout lifecycle. This includes SME support in implementation of Medical Devices and Combination Products in the RIM System (Veeva Vault RIM). Aim is to foster process- and system maturity. The individual capability activities are shaped to foster organizational change management in collaboration with the interfacing business functions and the other capability areas.
General remarks concerning the understanding of Capability :Client s understands as Capability: The interaction of processes, organizations, information, people and technology with their environment to deliver value and excellence to their customers. The core ambition of the Capability Leads is to: Drive business excellence, ensure compliance for GRA and enable innovation and digital transformation by owning and shaping fit for future GRA capabilities by means of proactively translating complex regulatory requirements and upcoming trends into tangible processes, prioritizing and focusing on critical needs and providing oversight, transparency and strategic advice for the organization.
Expertise of Role
The vendor staff requires strong global expertise in both regulatory environments): Medical Devices and In-vitro-Diagnostics framework Pharmaceutical framework 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
3. Project Management including project initiation, Organizational Change Management (OCM) and develop proposals for meaningful KPIs to be established in the Capability Area
4. Familiar with the harmonization efforts according IMDRF and former GHTF
5. Bridging of regulatory MD and IVD files to other regions, for marketed products
but also in context of Biomarkers in clinical drug trials
6. International handling of integral and non-integral Drug-Device-Combinations
7. Understanding of impact and options in management of MDs and IVDs in global clinical trials
8. Determination and Classification of Medical Devices and In-vitro diagnostics
9. Experience in global CDx development and complementary diagnostics
10. Familiar with international UDI and Medical Device Dossier requirements
More detailed description:
For this role, strong knowledge of both frameworks is essential to understand how they connect in areas like Combination Products, Companion Diagnostics, and clinical trial use cases. Staff must recognize key differences in terminology, collaboration, and risk management responsibilities to navigate tasks effectively. While the main knowledge required by the vendor is focused on Medical Devices and diagnostics regulation-aware critical thinking about the pharmaceutical development is mandatory to foster the appropriate level of interaction. Drafting, aligning, establishing and pursuing milestones and project tasks are requested in this context and should be supplemented by cross-hierarchical and cross-functional communication skills to prepare related decisions.
Specific individual tasks:
Definition of processes, roles & responsibilities, process-metrics and -reporting
Writing, creation and development of SOPs and Quality System documents including necessary preparatory interactions
Ensuring needed organizational change management to successfully conduct our current on-going Clinical trial Review concerning MDs and IVDs used in Clinical trials.
Organizational change management activities in collaboration with the business Functions
Establishing ways of working (global level), Special focus (but not limited to) on activities related to:
RIM Implementation (Veeva technology) for Medical Devices
Monitoring and capability supervision of our internally on-going Clinical Trial Review on the usage of Medical Devices
Establishing collaboration (with the teams as guided by our GRA staff) for 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); Combination Products; Borderline & Classification questions
Identify opportunities and needs for training and communication of MD/IVD related topics
Service Scope of Role
This role profile is dedicated to identifying, conceptualize, plan, align and execute Capability activities related to the Capability Area of Medical Devices and Diagnostics . The workload of this role profile comprises of about 70 hours per week. The vendor shall provide options to scale up or down the amount of work upon need.