Regulatory Project Manager IVDR

Location Eindhoven, Gemeente Eindhoven, North Brabant
Discipline: Medical Device
Job type: Temporary/Freelance
Contact name: Selin Ozbeden

Contact email: s.ozbeden@panda-int.com
Job ref: 13333
Published: 23 days ago

For one of our leading Medical Device clients I'm looking for a Regulatory Project Manager with IVDR experience. 

RESPONSIBILITIES

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

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


START DATE
       •  ASAP

PROJECT DURATION
       •  6 months (high chance of extension)

Interested?
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information please contact Selin Ozbeden on   +31 (0)20 20 44 502
https://panda-int.staffingreferrals.com/meet/sozbeden1