VP Regulatory Affairs Orthopaedics – Italy


The Context

One of Guided Solutions’ key clients, a cutting-edge implantable Orthopaedic technology manufacturer, had been expanding steadily over a two year period.

The company had originally spun out of a leading research institute with the sitting CEO a member of the university research team. All matters on Regulatory Affairs, Product Delivery and Research & Development had been the direct responsibility of the CEO and a carousel of temporary consultants contracted when necessary.

The business was beginning to shake off its institutional roots and move towards fully-fledged company status ready to take some ambitious commercial steps, eyeing significant funding. On this basis the CEO was becoming increasingly preoccupied with matters of strategic leadership so the decision was taken to hire a permanent Vice President of Regulatory Affairs.

The Campaign

The role was created to provide a strategic oversight of all international device accreditation processes and keep the company ahead of impending regulatory changes to those pathways in the coming years.

The candidate for this position needed to have a demonstrable track record of hands-on management of regulatory affairs within a micro-sized entity working with a Class III device. The technology used in the device development process meant that this classification might be subject to change with the coming regulation – an eventuality that would have to be planned for. The final key consideration was exposure to multi-accreditation approval planning. This was especially important given the CEO’s commitment to obtaining further VC funding to keep the business on track to achieve its ambitious scale-up objectives.

Guided Solutions were able to draw up a shortlist of 10 candidates with a blend of attributes that made them a theoretical match for the position. The subsequent methodology involved filtering candidates based on behavioural tendency and predicting their ability to manage the myriad stresses and responsibilities forming the role’s distinctive character.

After video interviewing, psychometric profiling, and key competency assessment of five candidates, two were chosen to progress to the advanced interview stage.

The final stage involved the preparation of a hypothetical regulatory approval plan for both the US and EU as well as a deeper discussion around candidate motivations and ambitions. The successful candidate was selected based on their demonstration of the dynamism, speed of thought and track record of delivering solutions to complex problems within testing time constraints.

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