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Navigating Regulatory Landscapes and Gaining Insights Into Compliance Frameworks
Hiral Vora
Hiral Vora
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Navigating Regulatory Landscapes and Gaining Insights Into Compliance Frameworks

Provide a comprehensive understanding of the regulatory environment governing medical devices.

Register today
Apply now
Tuesdays
 at
3:00
P.M.
 ET /
12:00
P.M.
PT
8 weeks, 2-3 hours per week
Beginner
No experience required
No experience required
Some experience required
Degree and experience required

Description

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.

Session timeline

  • Applications open
    March 11, 2024
  • Application deadline
    April 7, 2024
  • Project start date
    Week of July 8, 2024
    Week of
    April 29, 2024
  • Project end date
    Week of

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
Build Projects are 8-week experiences that operate on a rolling basis. Selected participants engage in weekly live workshops with a Build Fellow and 2-15 other students.

Project workshops

1
Introductions
2
US Regulations
3
EU Regulations
4
Regulatory Approval Pathways
5
Quality Management System
6
Advertising and Promotion
7
Introduction to Software as Medical Device
8
Presentation & Conclusion

Prerequisites

  • Regulatory Interpretation: Understand complex rules for medical devices across regions.
  • Research and Analysis: Good at finding and understanding regulatory and market information to make smart decisions.
  • Communication: Being able to explain regulatory ideas or ask questions when they don't understand something.
  • Critical Thinking: Ability to think carefully to spot problems and find solutions when dealing with regulations.

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About the expert
Hiral Vora
Visit
Hiral
's Linkedin

Hiral Vora is a Regulatory Affairs Fellow at Open Avenues Foundation, where she works with students leading projects in the Regulatory Field.

Hiral is a Lead Quality and Regulatory Affairs Specialist at Elucid Bioimaging, Inc. where she works on medical device submissions and ensuring compliance with the regulations.

Hiral has 4.5 years of experience as a regulatory specialist. Throughout her experience, she has participated in many audits for the company and communicated with regulatory authorities on various occasions.

She holds a degree in Regulatory Affairs.

A fun fact about Hiral: Her go-to comfort binge watch TV show is F.R.I.E.N.D.S and she has seen the entire series more than 7 times.

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