TEXT: 415-425-4961

S1:E7 | #7 – Solving FDA Regulatory Puzzles With Roxanne Dubois

UMN Roxanne Dubois | FDA Regulatory Puzzles


Roxanne Dubois has represented medical device companies as the primary liaison with the FDA and Notified Bodies for over 25 years. Roxanne forms collaborative working relationships with representatives of regulatory agencies to obtain clearance/approval for 510(k)s, IDEs, PMAs, and Design Dossiers for new medical devices and device modifications. Roxanne has hands-on experience writing regulatory applications (including three Original PMAs), responding to Agency questions and meeting in-person and by teleconference with FDA representatives. Roxanne’s experience also includes initiation of Quality Systems for start-ups, approval of new manufacturing facilities and facilitating on-site inspections by Regulatory Agencies (QSR, BIMO, pre-PMA, new facility, and inspections by Notified Bodies and a Competent Authority). While mostly focused on Regulatory and Quality, she also has experience with Clinical Affairs and combination products.

Roxanne has served as the VP of Regulatory Affairs and Quality at SI-BONE, VP of Regulatory Affairs at Tenaxis Medical, VP of Regulatory Affairs and Quality Assurance at Carbylan BioSurgery, Inc., VP of Regulatory Affairs, Clinical Research, and QA at ReGen Biologics and also as the Director of Regulatory Affairs at several mid-sized companies including Kyphon, Collagen Corporation, and Cohesion Technologies. She has also consulted for medical device companies in various fields such as orthopedic, gastroenterology, women’s health, dental and cosmetic surgery. Roxanne has a Bachelor of Science in Biochemistry from Cal Poly, San Luis Obispo.

Listen to the podcast here


Solving FDA Regulatory Puzzles With Roxanne Dubois

Wendi, welcome to the show.

Thank you.

You’re the president of the SHRM Foundation. We get to talk about my favorite talent, veteran hiring veteran initiatives. SHRM is the organization for doing great things with human capital. Since I’m a veteran enlisted officer, I went on to great veteran programs. I’m so glad that on my last day at the conference, I get to interview somebody doing something for my brothers and sisters in arms. Tell me about your role and all the initiatives.

I’m President of the SHRM Foundation. We’re the 501(c)(3) philanthropic affiliate of SHRM and we focus on mobilizing each of our professionals to be positive with social change in the workplace. HR professionals are so well positioned and have the opportunity and the obligation to put and do well so that people, community, and businesses thrive. We focus our work on four key areas. The first is what you would think is a foundation for a professional society. It would focus on scholarships and developing the next generation of the HR profession.

We have mentoring programs. We have about 300 students on-site at the conference. We’re proud of that. We’re seeing tremendous interest and a rising interest in students who are interested in pursuing the HR profession because they’re looking for jobs with purpose. in fact, one of our taglines for student programming is “Pursue Your Purpose.” We’re very excited about that.

The sooner a company brings in the regulatory person, the better. It doesn't mean they have to stay with lots of hours and expenses, but a regulatory person can come in and out of projects as needed. Click To Tweet

One of the best quotes that we have in our book, The Talent War: How Special Operations and Great Organizations Win on Talent, is from Tracy Keogh, who I used to work for at HP. Somebody went to her and said, “I’m glad the HR is at the table.” She said, “The HR is the table.” I’ve loved it ever since. To your point, even students are figuring out that the only thing that matters for your company is people.

People and culture drive everything.

I felt backward in the future. It was accidental. Somebody said, “Can you do recruiting?” I was like, “I can do recruiting well.” It’s great to see. By the way, I don’t have to do this. The show did a lot of surveys. The number one job out there is for HR.

Everything that’s happened over the course of a few years, companies and organizations, not all of them are realizing how incredibly important HR professionals are. They are on the front lines, at least engaging and taking care of their workspaces. Their people are the most important asset that a business has.

We have two wonderful producers of our show who had me writing blogs. They came up with this idea in the housing crash. Everybody focused on CFOs, and so we wrote this blog about the era of the CHRO to point out the pandemic and the changing workers. If you don’t have strong HR, you were so far behind the power card, but I could go on about strategic initiatives of HR all day.

UMN Roxanne Dubois | FDA Regulatory Puzzles
FDA Regulatory Puzzles: Reach out and talk to people. You have to trust your gut and go with what’s comfortable and where your interests lie.


I’ll tell you a little bit more about the foundation. I’ve got students of all ages. We’ve got students who were non-traditional students, folks who decided to go to school to pursue a Bachelor’s or Master’s in HR. Some of our students are right out of high school and have decided that HR is the profession of choice for them. I am a recovering HR professional, too.

Before I went to an association in nonprofit work, I worked for high hotels in Chicago. I did recruit, just like you did. Some of our other work is all around workplace mental health and moms. That is a huge topic. We identified this a few years ago at the foundation in SHRM, knowing that as we eventually came out of COVID, everything else that our families, friends, and people in the sphere of our care, if not ourselves, have been stressed and feeling, it was going to be one’s mental health.

HR professionals have this tremendous opportunity, an obligation to at least support their employees who come to work wherever that workplace or space may be every single day. Not only HR professionals in that regard but also helping people managers recognize signs of stress or distress on behalf of their employees so they can cure me at the earliest stage possible.

That’s got to be great work. One of the things that I’ve shared with acquisition and HR professionals is that we need to be out there thinking ahead. You guys were years ahead. This is a great example where HR is leading the way. I love that. If you’re at the point of educating and hiring, we need to be consultants. We need to be leaders. We need to be sharing that stuff.

It’s a team of people that are there dedicated to taking care of their employees. One of the things that I like most about this Workplace Mental Health and Wellness Initiative is the opportunity to address the stigma that often comes with an individual if they are challenged, feeling stressed, or anxious. We heard at one of the breakout sessions that someone was perhaps suicidal. The more we can do to recognize the signs and intervene to get ahead of when an employee is struggling is so important. It takes HR and people managers.

What is great about consulting is you keep meeting new people. Click To Tweet

It’s something that people have no idea how to handle. They will tend to run away.

In terms of the pillar of work, there are tools and resources on the SHRM website and the SHRM Foundation website for HR professionals and people managers. We also focus on skilling and reskilling. We’re helping individuals who have been perhaps misplaced or displaced and are looking to get back into the world of work or into the world of work at all as quickly as possible. This is a newer initiative for us. We’re working with HR professionals to think differently about the kinds of experience they experience and the increased technical skills that they require that candidates have.

Experience is only sometimes predictive of future success. It’s your character attributes. It’s the DNA that you bring. I’ve beaten myself up pounding that drum that you have to look for the talent. Don’t look for those requirements. Maybe there’s something that they prefer and we’ve made the point. You’re not hiring an intern being CEO. We get that. Experience does count. With the shortage of talent, reskilling is huge.

It’s huge, leading to my next pillar, which is untapped talent. Individuals like veterans, members of the military community, individuals who are disabled, individuals who have been formerly incarcerated or impacted by the justice system, and those populations or audiences are not necessarily disparate. It could be a veteran who is disabled and has been impacted by the justice system.

The point of our whole untapped talent initiative is to help those audiences get back into the world of work as rapidly as possible. Help HR professionals and people managers create hiring strategies designed to recognize, understand, and be open to individuals who often face stigma and bias when applying for jobs. Our Veteran at Work Initiative was the first one the foundation did. I started it a few years ago. In 2016, we launched our first Veterans at Work Initiative.

UMN Roxanne Dubois | FDA Regulatory Puzzles
FDA Regulatory Puzzles: As a regulatory expert, being knowledgeable about the guidance documents and knowing how the procedure of getting clearances and approvals works is key.


As a veteran, thank you for doing that.

It’s been popular. In fact, we have members of what we’re calling our veterans’ ambassadors here on-site at the conference. Those individuals have expressed deeper interest in taking on the role of being a trainer and training as many HR professionals and people managers as they can about the benefits of hiring veterans and members of the military.

I’ve built a number of veterans’ programs. It was always a struggle to educate both hiring managers and HR professionals. One of the things that I’ve said to HR professionals is, “We are the experts on human capital. We have to find the talent. We have to find the attributes.” I remember starting out, I would show a resumé of a veteran. They’re like, “Why are you showing me this?”

Why do you translate it?

How do you translate it? Educating HR professionals to say, “It’s not just in your short talent. This is what talent looks like. I serve. We call it the great leadership incubator. I would never be where I am if I didn’t have patience, the mentorship, and the coaching that I got in the military,” which was official. For me, it’s been selling myself, but it’s so great to hear that SHRM has been doing this. It is the most passionate thing for our veterans.

When you think of your job as problem-solving, you can have a whole spectrum of answers. Click To Tweet

When you think of your job as problem-solving, you can have a whole spectrum of answers.

My father was in the Army and both my grandparents were in the Army. Ironically enough, when my dad came out of the military, he became CHRO. My grandfather was the Director of Personnel and he played the bass for the Denver Symphony Orchestra. I’ve got a family history of veterans and of HR, which is my why.

What I notice and understand about veterans is they bring jobs into companies with this tremendous sense of commitment to the mission, teamwork, and leadership. Those things are implicated in their souls. People need to realize and recognize that beyond what they have, find ways when we’re interviewing to get those stories and help veterans tell their story of how those characteristics they have applied while they work in service. The HR professional can translate in their mind how those skillsets will translate well to the workplace.

I spent so much time helping veterans be able to tell that story because I can’t account for that when they get out of those transition services, wherever they need to be. I’m so grateful that SHRM played a big role in this because you have to educate both sides of the equation about how veterans articulate, what they learn, and what they bring to the table. We will tell their story. We’ve got to train people to listen to them because of the stick-to-itability, the drive, the passion towards the mission. Every survey that I’ve ever done on veterans for retention always gets 10 to 15 points higher.

Companies that hire diverse talent are 35% more financially successful than companies that don’t. It’s the right thing to do. We always meet with the business case for hiring veterans, individuals with disabilities, and those who have been incarcerated. It makes the best business sense.

UMN Roxanne Dubois | FDA Regulatory Puzzles
FDA Regulatory Puzzles: Having that expertise at the very beginning, even if it’s just a few hours here and there to bounce off what you think is the right approach, can save you a lot of time and energy.


I’m going to give you a great question to close this out. Most of the people that end up reading this end up being either hiring managers for C-Suite and HR professionals. If you were going to give the best advice on how to get that mindset right about hiring those untapped talents, what advice would you be giving HR professionals?

Do your homework and do some research. We have tremendous research on our website through a partnership with SHRM that talks about the value that veterans and untapped talents. Understand the value that you as an HR professional can bring into your place of work if you deliberately set out to develop a strategy to hire veterans.

I would also encourage HR professionals to know that one of the best ways to activate a DE&I strategy is to hire diverse populations of veterans. Maybe your company is trying to get there. You are more reflective of your customer base when you have a diverse population in terms of employees. People are more satisfied when they see themselves working with people who look like them but are bringing different lived experiences to the table. They’re learning from one another. You’re developing happier employees sum total. It can be incredibly inspirational to be an HR professional and have the ability to change somebody’s life, even just one at a time.

You are taking care of people’s lives. I love the diversity. I came from the military. My co-author and I say all the time, “Everybody’s thinking like everybody’s thinking.” I can’t thank you enough for, first and foremost, not just for coming on but for working with veterans. It’s been a lifelong passion of mine. I am so grateful for all that you guys do.

Thank you. It is truly an honor to lead a team in the foundation that is so committed to this work sum total.

Thank you so much.

Thank you.


Important Links

Leave a Reply

Your email address will not be published. Required fields are marked *