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Msra Harsh Raja

Regulatory Affairs Labeling Specialist at Zimmer Biomet

Msra Harsh Raja is a dedicated professional with a robust background in Medical Devices and a comprehensive knowledge of FDA regulations and submission requirements. Skilled in 510(k), PMA, and IDE processes.

Her expertise extends to ISO standards, Quality System Regulations, CAPA, CE marketing, USFDA regulations, ICH regulations, and quality compliance. She also possesses knowledge of laws and ethics related to protecting participants in clinical trials, along with proficiency in Six Sigma, Lean Six Sigma, and Change Management.

Msra is adept at utilizing various technical tools including Microsoft Office suite, Microsoft Project, Microsoft Visio, Microsoft Access, Sharepoint, Adobe Acrobat, and Wordpress. She completed her Master's Degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University.

With a strong educational foundation that includes a Master's degree in Project Management from Harrisburg University of Science and Technology, a Bachelor's Degree in Pharmacy from VES College of Pharmacy, and high school studies at Mithibai College of Arts Chauhan Institute of Science and Amrutben Jivanlal College of Commerce and Economics, Msra has honed her skills in the industry.

Her professional experience spans roles such as Regulatory Affairs Labeling Specialist and former Regulatory Affairs Specialist at Zimmer Biomet, former Regulatory Affairs Specialist at Philips, former Regulatory Project Coordinator at Lilu, Inc, former Regulatory Affairs Associate at DAMAE Medical, and former Regulatory & Health Compliance Intern at Nutrimedy.

Msra Harsh Raja
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Location

Palm Beach Gardens, Florida