Project Leadership: EU Medical Device Regulation Compliance

In my role as a business leader overseeing a portfolio of 200+ unique products, I successfully guided the organization through the complex and evolving landscape of EU Medical Device Regulation compliance. This initiative was executed on time and within budget, involving a global team of over a hundred members strategically located to ensure effective collaboration and communication.

To streamline the compliance process, I developed a comprehensive submission plan that meticulously considered the backlog within our notified body partners. This proactive approach allowed us to prioritize submissions efficiently and facilitated timely reviews and recommendations for our products to be marketed in the EU.

By fostering a culture of accountability and collaboration, I ensured that all teams were aligned with regulatory requirements and business objectives. This rigorous compliance strategy not only safeguarded our market access but also reinforced our commitment to delivering high-quality medical devices to our customers.