Navigating Regulatory Landscapes and Gaining insights into Compliance Frameworks
Provide a comprehensive understanding of the regulatory environment governing medical devices
Hiral Vora
Open Avenues Foundation
Tuesdays, 4:00 P.M. ET / 1:00 P.M. PT
8 weeks, 2-3 hours per weekDescription
In this Build Project, you'll step into the role of a Regulatory Affairs Specialist and tackle the challenge of navigating the complex and variable regulations governing medical devices. Working under the guidance of an experienced industry expert, you'll develop a regulatory strategy document that addresses the nuances of regulations across different countries. Through this project, you'll become proficient in interpreting guidelines and ensuring compliance, gaining valuable skills essential for success in the medical device industry. You'll also gain insights into maintaining consistent adherence to quality management systems, a crucial aspect of any medical device company's operations.
Application timeline
What you will learn
- Proficiently navigate medical device regulations, including FDA requirements and international standards.
- Will learn how to craft regulatory documents, defining submission requirements, timelines, and risk management considerations.
- Familiarity with implementing quality management systems (QMS) using tools like ISO 13485.
- Knowledge of regulations for Software as a Medical Device (SaMD), including classification and concepts for successful market entry.
Project workshops
Prerequisites
- Regulatory interpretation skills to understand complex rules for medical devices across different regions.
- Research and analysis skills to find and interpret regulatory and market information for informed decision-making.
- Communication skills to clearly explain regulatory concepts or ask clarifying questions when needed.
- Critical thinking abilities to identify issues and develop solutions when navigating regulations.
Apply Now!
Ready to start this exciting project? Submit your application today and begin your journey with Build!
About the Fellow
Hiral Vora
Open Avenues Foundation
Visit Hiral's LinkedInHello, I am Hiral Vora, Regulatory Affairs, Global Talent Fellow at Open Avenues, where I work with students leading projects in the Regulatory Field. I completed my Masters in Regulatory Affairs from Northeastern University. I am a Lead Quality and Regulatory Affairs Specialist at Elucid Bioimaging, Inc. where I work on medical device submissions and ensuring compliance with the regulations. I have 4.5 years of experience as a regulatory specialist. Throughout my experience, I have participated in many audits for the company and communicated with regulatory authorities on various occasions.