Case study

VP, Global Regulatory Affairs, Mid-Cap MedTech Company

USA
A doctor in a white coat is gesturing at three floating checkmarks, representing accomplishment and reliability, in a bright, blurred medical setting.

THE CHALLENGE

Our client was a mid-cap MedTech company with multiple business units and was for the first time bringing each division’s Regulatory Affairs teams under a single leader. The newly created position would be responsible for all regulatory activities for the company globally.  

The main challenge on this search was finding someone ready to join an ambitious, multi-year innovation journey, including three original PMAs. Consequently, we required a leader who possessed the rare experience of multiple end-to-end PMAs for Class III implantable medical devices.  

Additionally, our client intended to elevate the role of the Regulatory Affairs organization in the company, transforming the perception of the team from being a back-office administrative function to a crucially important strategic advisor to the business. 

THE SOLUTION

The most difficult aspect of this search was finding candidates who’d led an original PMA from developing the regulatory strategy for the new product to securing FDA approval, ideally looking for someone who’d done so more than once.  

We solved this by first building a comprehensive view of companies with Class III implantable devices in their portfolio. We covered the full spectrum from stents and valves to neuromodulation devices to intraocular lenses and beyond.  

We then mapped out current and former regulatory leaders at these companies, prioritising those with long tenures- given how long PMAs can take, candidates who’d only spent 2-3 years at one of these companies could not possess true end-to-end original PMA experience.  

Finally, we crafted a compelling narrative grounded in what truly motivates candidates—and zeroed in on three powerful messages:  

  • A “once-in-a-career” experience, owning three original PMAs as a Regulatory leader in MedTech. Not only does the opportunity represent a massive resume boost, it’s likely to be the most difficult, rewarding, and memorable experience of your career.  
  • Leading the evolution of the company’s Regulatory function. Elevate the team’s capabilities, redefine their role in strategic decision-making, and leave a lasting legacy on how Regulatory is viewed company wide.  
  • Join a mid-sized organisation that’s more stable and well-resourced than a start-up, yet as agile and fast-moving as a smaller player – the best of both worlds. 

THE RESULT

In the end, we presented a highly capable shortlist of candidates, bringing end-to-end PMA experience from a variety of MedTech product categories. Following a thorough and competitive interview process, a selection was made, and a top-tier talent was hired.

The impact

In just a short period of time, the new leader has been tremendously affective at developing the regulatory strategy to optimize for the quickest route to approval while achieving the most competitive labeling for their new products. They’ve also taken swift action to uplift the internal team, bringing in additional high-caliber talent and raising the bar across the board. The company has a stronger Regulatory function than ever as it moves down the path on its innovation journey.