ABSTRACT
The role of the Regulatory Affairs department is evolving from that of a subject matter expert to becoming a business partner working closely together with the commercial team and other departments in order to ensure the successful implementation of the company’s strategies. Regulatory matters can sometimes be seen as hurdles and challenges delaying the launch of new products. For many medical device products, the North American and Western European markets are slow growing, while the competition is fierce, customers are increasingly cost conscious when healthcare spending is under scrutiny, and markets are saturated. The medical devices industry is increasingly becoming a global business, with local companies adding global growth ambitions and multinational companies looking to ensure they balance established positions in mature markets with growth opportunities in emerging markets.
