Recently, our Founder and CEO, James Gianoutsos, was a guest on an episode of the Easy Medical Device podcast. Hosted by Monir El Azzouzi, a quality and regulatory professional with over 16 years of industry experience, the Easy Medical Device podcast explores a wide range of topics, news, and challenges to help medtech quality and regulatory professionals gain valuable insights that will help them excel in their roles.

In the episode, Why should you invest in your regulatory team?, James and Monir explore the limitations of traditional cost-center approaches to resourcing and preparing budgets for regulatory affairs teams and discuss the benefits of treating regulatory affairs as a revenue function. Hear their thoughts about:

• How regulatory affiars teams are typically structured
• The importance of the RA job function on revenue
• The impact AI will have on regulatory affairs
• How digital tools can enable RA teams

James also provided tips RA professionals can use to convince their stakeholders to invest in regulatory affairs teams. He emphasized that getting buy-in often involves a mindset shift that will change the dynamic of the conversation. For example, when planning for a renewal, think about the financial impacts of missed renewals rather than the sheer volume of renewals you're doing.
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When you're trying to convince your leadership team, don't talk about how many renewals I did for this product in a particular month. talk about the dollar figures you saved the company or retained on the market.

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For more tips, listen to the full interview on the Easy Medical Device website.