MCRA's world class know-how and execution unlocks barriers, advancing our clients mission to better the availability of quality medical care to patients around the world.
Kimberly Lubragge
Overview
Kimberly Lubragge is an accomplished quality and compliance specialist with over 20 years of experience in project and quality system management. Areas of expertise include quality document and data management, computer system validation, change control and auditing. Kimberly is a cross functional team leader with a focus on achieving measurable quality results through continuous process improvement.
Kara Budor, M.S.
Overview
At MCRA, Kara Budor is Director, International Regulatory Affairs and primarily focuses on international regulatory strategy and submissions for various device types including, but not limited to, orthopaedics, spine, dental, imaging, respiratory, general surgery, and biologics. Kara works with clients and colleagues on regulatory strategy, analysis, and development; submissions and interactions with regulatory bodies; and design, review, and implementation of documentation and testing.
Tim Sutton
Overview
Mr. Sutton supports US and international regulatory strategy and submissions for the MCRA Regulatory Affairs department. Mr. Sutton specializes in writing and reviewing regulatory submissions, developing overall regulatory strategy, and communicating with regulatory bodies and clients. MCRA’s Regulatory Affairs department has the staffing expertise in the neuro-musculoskeletal disciplines, and carefully cultivated relationships and experience with U.S. government agencies enabling clients to operate, expand, and achieve their long-term business objectives.
Lucas Tatem, M.Eng
Overview
Mr. Tatem’s work at MCRA focuses primarily on regulatory affairs relevant to spine and orthopedic medical devices.
Michael Coladonato
Overview
As a manager of regulatory affairs, Michael manages and supports various US and EU projects in the spine and orthopedic therapeutic area.
Erin Mundstock
Overview
At MCRA, Ms. Mundstock supports CRO operations and provides oversight and management for all aspects of the development and execution of clinical trials/protocols including adherence to study timelines and budgets. Prior to MCRA, Ms. Mundstock spent 12+ years leading IDE clinical trials in the medical device start-up space where she partnered with multiple individual vendors and clinical sites to provide reliable clinical evidence to support regulatory approvals.