IVD Product Development Manager

Zenopa Client is a diagnostics company focused on diseases of the gastrointestinal tract. Our current research and validation programme targets accurate and efficient triage of patients with symptoms of colorectal cancer (CRC).

Our Client are recruiting for a Product Development Manager to join in the development of new IVD Devices. The IVD Product Development Manager will lead the development of IVD devices working closely with our Regulatory, Quality, R&D and Clinical teams. The position combines project management and hands-on activities, providing a unique variety to the role.

The IVD Product Manager will lead the scientific development and validation of an IVD using next generation sequencing system with the objective of meeting UK and EU regulatory requirements for commercialisation. The successful candidate will have the ability to apply laboratory skills and experience working in the regulatory environment for IVD product development.

Projects must be documented to relevant medical device standards and must be conducted in accordance with ISO 13485. As an IVD Product Development Manager, your main responsibilities would be:

Liaise with regulatory teams, and provide input into the technical and procedural requirements for IVD certification to ensure UKCA and CE compliance.
Manage development projects from requirements definition and concept development through to transfer to commercialisation, using internal and external teams as required.
Management of resources, addressing capacity constraints as they may occur.
Monitor and report on project progress.
Create reports and presentations of scientific data and information.
Lead risk analysis discussions and preparation of the risk management file.
Co-ordinate and input into the design of verification and validation testing.
Prepare technical reports.
Work with the R&D team to obtain required technical documentation required under regulatory pathways.
Work with regulatory to compile required technical file documentation.
Ensure timely delivery of project milestones and provide suitable interpretation to managers and staff within the organisation.

Product development of Medical or IVD devices
Have an understanding of ISO 13485, and relevant device regulations e.g CE, IVDR, MHRA, FDA.
A solid background in a relevant field of IVD medical devices or related activities e.g. work in IVD industry such as research and development, manufacturing, testing.
Quality Management experience.
Knowledge of technologies, design and manufacturing of IVD medical devices, experience of different manufacturing processes and performance evaluation of a range of IVD devices across different risk classifications for IVD devices.

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