Interim RA Specialist

Job title:

Interim RA Specialist

Company:

Panda International

Job description

Introducing Panda Intelligence: Your Recruitment Partner in the Intricate World of Data and AI in Life Sciences↓Interim RA SpecialistInterim RA Specialist Location Utrecht , Netherlands
Business Sector Medical Devices
Contact name Caitlin Girdwood
Contact email
Job ref 24117
Published about 8 hours agoMy client is an innovative Medtech scale-up that is searching for an Interim RA Specialist to project-manage the interface with new distributors and involved consultants for Global Registrations (South Korea, Saudi, Mexico, Latam, SE-Asia, …Australia).Interview process: 1 Stage via teams with offer before Christmas
Start Date: January
Duration: 6 monthsKey tasks would be:

• Weekly project management meetings with various distributors/consultants regulatory professionals
• Build Clear regulatory pathway maps/gannt-charts per country per device with milestones, deliverables, requirements (Dossiers, local labelling), time lines, cost.
• Clear agreements with distributors and consultants on who creates what (dossier (re-)formatting, translations, addition country specific documents)
• Ensure all dossier updates are uploaded in our eDMS, approved by appropriate stakeholders and RA. Tracking of doc versions submitted.
• Transfer labelling requirements (IFU, patient cards, leaflets, box labels), possible eIFU etc., to RA and QA.
• Plan labelling changes implementation time lines with Operations, QA, RA.
• Chair weekly Dashboard for management with progress updates, issues, and escalations
• Chair weekly team meetings to update internal stakeholders in Marketing, Sales, RA, QA

Expected salary

Location

Utrecht

Job date

Sat, 14 Dec 2024 08:34:00 GMT

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