Meet is joining with an IVD manufacturer to support them on sourcing an experienced Reg Affairs consultant who will lead their IVDR project. They are based out of Oxford, UK and are looking for someone to be based on-site for a minimum of 3 days a week. a 12-month contract is on offer here so it's a great opportunity to work with a top business in the diagnostics space.
Provide clear, constructive regulatory advice and guidance to global project and product development teams regarding IVDR (2017/746) compliance.
Define IDS’ EU IVDR regulatory strategy and drive implementation of the strategy.
Preparation of Technical Files compliant to IVDR requirements for regulatory submissions for new and existing products.
Maintenance of existing global regulatory approvals.
Minimum of 5 years’ experience in Regulatory Affairs functions related to IVD device registration and on market support in the US. At least 2 of the 5 years should have been spent in a managerial position
Experience working in Regulatory Affairs related to IVDR remediation
Proven experience of interaction with Notified Bodies and/or Competent Authorities to elicit information or to achieve progress of regulatory submission