Regulatory project manager IVDR (Freelance)
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
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).