Mr. Lucas Tatem has five years of experience and expertise in scientific research and various aspects of regulatory/clinical affairs. Lucas is an accomplished regulatory technical writer and has experience in the development and implementation of regulatory strategy and regulatory submissions in therapeutic areas including spine, orthopedics, general and plastic surgery, and wound care.
Mr. Tatem earned a Bachelor of Science degree in Bioengineering (concentration in biomaterials) and Master of Engineering degree in Biomedical Engineering from Clemson University.
As a Manager of Regulatory Affairs at MCRA, Lucas leads and supports the development of regulatory submissions including, but not limited to Q-Submissions, 510(K)s, PMAs, IDEs, and INDs for client’s seeking FDA approval. Lucas also provides guidance on the development of regulatory strategies, product landscape analyses, recommendations for pre-clinical testing and analysis of clinical data. Lucas also has experience in drafting and preparing international (EU) regulatory submissions, namely Clinical Evaluation Reports, and performing comprehensive literature evaluations.
At MCRA, Lucas is responsible for developing and maintaining regulation-compliant electronic common technical document (eCTD) submissions to CDER and CBER. Lucas has led the development of eCTD submissions for Pre-INDs, original INDs, as well as master file letter of authorization filings.
Overview
Mr. Tatem’s work at MCRA focuses primarily on regulatory affairs relevant to spine and orthopedic medical devices.