Regulatory Framework in Healthcare: Useful Tips for Business Analysts

=> Register via this link:
https://dcmetro.iiba.org/events/regulatory-framework-in-healthcare-useful-tip/
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From initial concept to FDA submission, Business Analysts play an essential role in ensuring medical devices are developed with regulatory compliance and patient safety in mind. By driving clarity in requirements, supporting risk identification, and ensuring traceability between hazards, mitigations, and testing, a Business Analyst helps translate regulatory expectations into actionable and traceable requirements and designs. Their involvement in risk management activities, design documentation control, and stakeholder alignment supports the creation of submission-ready artifacts that meet FDA standards.
This session is designed for professionals supporting initiatives in both regulated and non-regulated industries who want to understand the FDA approval process and grasp the important role business analysts play in it.

Speaker: Iryna Sizikova, PMP, PSPO II
https://www.linkedin.com/in/iryna-sizikova-pmp%C2%AE-pspo-ii%C2%AE-4601646/
Iryna Sizikova has 18 years of experience in healthcare and currently works for a U.S.-based dental equipment and software manufacturer that markets its products in over 120 countries. She holds international certifications, including the PMP (Project Manager Professional) and PSPO II (Professional Scrum Product Owner). Currently, she is pursuing the CBAP (Certified Business Analysis Professional) certification.

Iryna's professional focus lies in developing and enhancing R&D processes, aligning them with industry standards, and scaling a unified approach to planning, design, and development across more than 40 Agile teams within the organization. In her current role as Chapter Lead of Business Analysis and Documentation, she develops and promotes strategies that simplify regulatory compliance and accelerate time to market for medical devices through effective business analysis.
Iryna also volunteers as part of the leadership team of a workplace community that supports people with disabilities. She is committed to promoting their physical and mental well-being and fostering an inclusive, supportive work environment.
A few personal facts...
Iryna was born and raised in Europe and has lived and worked on two continents. She speaks four languages, lives in a multicultural environment, and enjoys yoga and skiing. She is also working on earning her Private Pilot's License—yes, she can land a plane on her own!

Agenda:
Networking: 6:00-6:30
Presentation: 6:30 - 7:30 PM ET

Education Hours: 1.0 CDUs for IIBA Recertification
Location: Online via Zoom

Price: F R E E

Any questions? Contact the [board@iibadc.org](mailto:board@iibadc.org)

Event Location:
Online via Zoom; the link will be emailed to you with your registration confirmation

=> Register via this link:
https://dcmetro.iiba.org/events/regulatory-framework-in-healthcare-useful-tip/