Miriam brings over 20 years of medical device/regulatory experience to Nerac clients.

Miriam received her bachelor’s and master’s degrees in biology during which time she conducted laboratory- and scientific literature-based research. In her studies, she explored all levels of biology as well as the chemical processes of biological systems. After completing her degrees, she worked as a chemist for chemical and medical device manufacturers, such as Xttrium Laboratories and Bosworth Company, where she further strengthened her scientific knowledge and built her expertise in the regulatory environment. Additionally, she worked seven years as the Regulatory Affairs Manager for the Avent brand of Royal Philips Electronics. There, she managed the compliance of the brand’s catalogue of medical devices through their entire product lifecycle – from the research and development phase through post-market. This work included the writing of technical files for medical device submissions and standard operating procedures that met the requirements for FDA, Health Canada, and other government agencies.

Prior to joining Nerac she leveraged her strong scientific knowledge and expert writing skills to work for Cactus Communications as an editor of clinical research manuscripts before they were published into journals such as Frontiers, International Journal of Molecular Science, and Journal of Clinical Pathology.

“Medical device firms who incorporate regulatory compliance and risk management activities into the early stages of product development can have lower development cost, reduce delivery times, and ensure higher overall innovation efficiency.”