Our client high-tech analytics developer and manufacturer of GC-IMS instruments and solutions, secured international shareholders and set up a dedicated analytical division for medical and healthcare screening and diagnosis
They are seeking to hire an experienced self-starter being innovative, passionate, and a highly accomplished individual with a proven track record of sustained success in the execution of complex technical and high visibility projects in the clinical field with multiple projects running in parallel.
A successful candidate will work cross-functionally to assist in the implementation of effective and efficient plans, scaling the product lifecycles appropriately, and brings a strong continuous improvement approach to the development process. The role holder will lead a cross-functional core team in the development programs for a series of instrument and consumables development programs of an in vitro diagnostic device, ensuring delivery of the product through to its launch while ensuring compliance with quality system deliverables and regulatory requirements.
The role holder will have relevant industrial experience as an R&D Project Leader with oversite of complex programs; Expertise in PRINCE2 or PMP is highly desired. in addition understanding of agile project management techniques would be advantageous. Experience working within cGMP and ISO13485 is essential as well as applicable experience within a regulated environment (FDA/EMA/MHRA).
Experience leading core teams to the successful launch of A medical devices or in vitro diagnostic products is required and a successful track record of executing IVD development projects from the proposal phase to final implementation (Specific IVD experience can supplement years of experience and education requirements)