Veenpluis 4-6 Best Brabant NLD 5684 PC
Secondment via YER
Over deze vacature
Implementation of IVDR within DCP needs to be coordinated and supported by an IVDR SME to ensure timely certification of the main product PIPS to stay on the EU market per May 26, 2022.
Task 1: Project management support for EU-IVDR implementation within DCP
The objective is to support the implementation of EU-IVDR within DCP through executing project management activities. The activities would typically consist of the following:
- Interface with functional leads to start activities, ensure bottlenecks are addressed and monitor progress
- Maintain an overview of the total implementation of the EU-IVDR ensuring progress is made and risks are identified and mitigated or escalated
- Execute the project on a tactical level through initiating and ensuring follow-up of identified actions
- Interface with the EU-MDR/IVDR global team to initiate and monitor the transfer of the globally designed solutions into the DCP organization
Task 2: Regulatory Affairs Specialist for EU- IVDR implementation within DCP
The objective is to support the implementation of EU-IVDR within DCP through supporting the RA function. The activities would typically consist of the following:
- Identify and propose solutions to current RA & PDLM process (procedures and templates) for IVDR compliance
- Work in collaboration with RA specialist, QA and R&D to review the technical documents for IVDR.
- Maintain an overview of the implementation of the EU-IVDR
- Act as an Subject Matter Expert for IVDR implementation questions
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision-making.
You will be employed by YER and seconded to Philips. We offer:
- Good employee benefits
- Excellent guidance from your consultant and YER's back office
- Friendly atmosphere and open culture
- Community/network with other technology professionals from a variety of multinationals
- Events and master classes with interesting speakers and attractive companies
The regulatory affairs project manager would be working closely within DCP and would be expected to be on-site (when permitted in view of the pandemic restrictions).