6th Annual Medical Device Regulatory Affairs: Securing Clearance & Maintaining Compliance: Speaker Interview – Roberto Refeca/Halyard Health

Roberto F. Refeca roberto
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?

Session 1
Session 5 Part 2
Session 12
Session 14
Session 17
Session 21
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
NIOSH

At Veranex, we can help you with concept through to commercialization by enabling:
• Accelerated speed to market
• Controlled development costs
• Development risk mitigation
• Market viability assessment

At every stage, we navigate our clients to realize efficiencies in cost and time with our integrated and comprehensive solutions.

Visit Sponsor Website

Since TrainingPros was founded in 1997, we have been dedicated to helping our clients find the right consultant for their projects. 25 years later, we are proud to have helped hundreds of clients complete their projects and thousands of consultants find great assignments. We continue to focus on helping our clients and consultants as well as our community as a certified women-owned, award-winning staffing company that works exclusively with Learning & Development professionals to match consultants to client projects.

Visit Sponsor Website

TELCOR is the proven leader of health care software solutions for revenue cycle management (RCM) software and services designed specifically for laboratories. TELCOR RCM, our SaaS solution, and TELCOR Revenue Cycle Services, our billing service, are designed to streamline workflow, improve collections, and provide real-time analytics. Our software and service solutions are designed for the unique challenges and requirements of laboratory specialties and the clients they serve. With full access to data, labs have complete visibility of their data and can track key performance indicators. No other vendor works as hard ensuring you get paid for the work you do.

Visit Sponsor Website

At Tipping Point Media, we pride ourselves on developing innovative, creative, and technically advanced virtual training and digital marketing solutions for the life sciences industry.

We push the limits of what's possible using Augmented and Virtual Reality to create revolutionary experiences proven to increase audience engagement and retention rates.

Our dedicated team of educators, medical experts, certified programmers, and digital renaissance innovators are committed to creating high-quality custom creations that bring your company's vision to life.

Visit Sponsor Website

VantagePoint Performance trains Salespeople to be more fluent and comfortable across different situations needing different sales approaches, and we train Sales Managers to be better coaches and team leaders, with more focus and less stress.

We’re different from the average sales training company because:

We don’t believe that one approach, one system, or one methodology is absolutely superior. All have something to offer, and the “best approach” or “best system” depends on the sales situation. This is what our applied, academic research tells us.
Our use of data science, specifically Machine Learning, helps us learn about our clients more meaningfully. We provide insights from each client’s data to help them understand what drives the success of their top-performing Salespeople and Sales Managers.
We are constantly feeding what we learn back into our training products, and we invest a bigger slice of our total energy into this innovation than the average sales training company. Our clients can access always-refreshed intellectual property and content through our training subscriptions.

Visit Sponsor Website

Policy Reporter, acquired by TrialCard in 2019, provides innovative healthcare software solutions to track payer policies in near real-time and enhances market access for the therapies patients need most. The company’s patented software-driven solutions include a suite of billing and reimbursement tools for providers and laboratories, market intelligence tools for payers, and a suite of market access solutions for life science companies. Its clients include some of the world’s largest pharmaceutical and healthcare companies.

Visit Sponsor Website