Roberto F. Refecaroberto
Associate Director, Regulatory Affairs
Halyard Health, Inc.


Roberto F. Refeca is the Associate Director, Regulatory Affairs, at Halyard Health, Inc., a medical technology company focused on advancing health and healthcare by preventing infection, eliminating pain and speeding recovery. Roberto has over 10 years of experience in Regulatory Affairs (Domestic {PMA, 510K, IDE} and International {CE-Mark Design Dossiers, Tech Files, Design Dossier Amendments, Major Applications (Class II-IV) Canada, Brazil, Mexico, Australia, China, Japan, and Clinical Trial Applications-Canada. Roberto has primary author experience/and has lead teams to successful registrations WW of Class II-Class III products including Neurovascular Stents, Combination Products (Drug Eluting Stents), Neurovascular/Peripheral/and Coronary Guidewires and Catheters, Active Implantable Medical Devices (AIMDs)/Ventricular Assist Devices (VADs), Digestive Health Products, Respiratory Health Products, Active Devices, Surgical and Infection Prevention Devices and Brazil-ANVISA GMP Inspections. Roberto has managed direct communications with the US-FDA, Health Canada, Australia-TGA, and the Costa Rica MOH, and managed/supported major company initiatives such as establishing OUS Manufacturing sites and most recently the RA lead managing the separation of Halyard Health, Inc., from Kimberly-Clark.


Roberto will be one of the distinguished presenters at the 6th Annual Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance Conference.


Why is the 6th Annual Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance Conference important to regulatory affairs executives?
Provides a wide portfolio discussion on RA topics, and provides immediate resources (presenters and attendees).


How has Regulatory Affairs evolved in the last several years?  

  • RA Requirements WW continue to be updated/changing/emerging
  • Regulatory Intelligence continues to be a key priority


What initiatives are on the horizon at your organization in 2016?
All companies/continuously seek growth


Why is this conference important to you as an industry leader?
Provides an opportunity to learn/stay current with RA topics and provides a peer to peer opportunity.


If you had to describe Regulatory Affairs in one word, what would it be?
Changing, Keep Up.


What topics are you most excited about for the conference program this year?

  1. Session 1
  2. Session 5 Part 2
  3. Session 12
  4. Session 14
  5. Session 17
  6. Session 21
  7. Session 24


What are the “key takeaways” for your presentation/panel discussion?
Not just thinking as an RA professional, thinking as a part of the business, a partner to the success of the business.


Are there any blogs, forums, industry associations that you follow in relation to Regulatory Affairs?

  • RAPS
  • US-FDA Updates