Michael Edwards has more than 25 years of experience in regulatory affairs and quality assurance acquired within the medical device and clinical research industry. He has worked across a diverse range of medical device technologies, therapeutic disciplines, and organizations from start-ups to multinationals.
Michael Edwards expertise spans the complete product lifecycle including clinical research, design, development, technical support, project management, operations, and business development in the medical devices sector. His knowledge of the device development process, combined with the regulatory requirements, enables him to provide a balanced interpretation of the pre-market and post-market needs and expectations of regulatory authorities.
In his current role, Michael provides regulatory, quality, and technical expertise to clients and sponsors to help bring their products to market safely, effectively, and efficiently. His key strengths include developing, formulating, and implementing regulatory strategies for device development and pathways to market to meet both existing and new regulations, standards, and guidance documents.
Prior to joining Premier Consulting, Michael has held various senior management positions in regulatory affairs, quality assurance and technical with high-profile, international medical device and clinical research organizations.