Sade Sobande, RAC's Linkedin Analytics

As a lead consultant at Emergo by UL, I help medical technology companies navigate the complex and dynamic regulatory landscape. With a RAC-Devices certification and over 12 years of experience split across regulatory affairs, product development, and manufacturing, I have the knowledge and skills to support a range of clients from start-ups to multi-nationals, with specific expertise in MDSW. My core competencies include software technical and regulatory support, global regulatory strategies, technical file authoring, QMS remediation, audit support, product lifecycle maintenance, and regulatory leadership. I have successfully led and contributed to regulatory submissions, product registrations, and renewals in various markets, such as EU, US, Canada, MENA, and APAC. I am also proficient in relevant standards and regulations, such as ISO 13485, FDA QSR, ISO 14971, IEC 62304, IEC 60601, and ISO 19011. My mission is to ensure the safety and efficacy of medical devices and improve the quality of life of patients. I work effectively within and leading cross-functional and cross-cultural teams, and I am passionate about ensuring everyone has a voice and a seat at the table.