Loyola University Chicago School of Law, J.D. 2018
Dominique Vittori is a Regulatory Affairs Associate for Abbott Laboratories working within Abbott Diagnostics Division. Abbott Laboratories is a worldwide healthcare company that is most known for pharmaceutical development but eventually branched out to include medical devices, nutritional products and research-based drugs/pharmaceuticals. Ms. Vittori earned her Bachelor’s degree from the University of Illinois, where she majored Molecular and Cellular Biology. Ms. Vittori sought a career in compliance because of the opportunity to put her background and expertise in the sciences to use in a corporate setting, and has been most rewarded by the ability to see the tangible results of her work at Abbott Labs.
The following is an interview with Ms. Vittori where she gives an inside look into her daily life as a compliance professional.
What does a typical day look like for you? What are your responsibilities within the office?
The primary responsibility of anyone working within Abbott’s Regulatory Affairs department is overseeing the full development of the product life cycle, starting with research all the way to the post-market processes to ensure the product is fully compliant. Because of the depth of duties that my division handles, I’m fortunate in that every day is different in terms of responsibilities—but the diverse projects I encounter have made me a more well-rounded professional. Currently, I am focused on tracking the regulations surrounding US export products, labeling reviews of the products, and FDA submissions.
The products that are exported out of the US ultimately end up going to market in over 150 countries that Abbott works with, so there is a lot that goes into a smooth export process for each product. Label reviews of the product entails arriving at a unique identifier for each specific product, and the labels help both consumers and the labs understand what it is inside it. It’s a crucial component of the business because these labels list the warnings and the ingredients specifications of what the product is comprised of to ensure proper use.
Another significant component of my daily responsibility is managing the CLIA submissions to the FDA. CLIA stands for Clinical Laboratory Improvement Amendments and was created to regulate laboratory testing that requires all labs to be CLIA certified in order to use any human body-derived samples for diagnostic tests.
What are the most frequent compliance/ethics issues that your office deals with? What are some of the biggest issues facing the industry as a whole?
The issues in our office are more often than not industry wide issues as well. I believe the largest issue Regulatory deals with is the simple possibility of failing to comply with the regulations and laws that are set forth for the products. The repercussions of this could be fines, audits, inspections, etc. as well as the possibility of lost trust of the consumer.
Another issue that is more focused in global companies such as Abbott is the communication and timelines with the affiliates of different countries. Working for such a global corporation like Abbott requires communication through different languages, cultures, timetables, and approaches, but strategy alignment isn’t always the outcome. For example, sometimes a product is sourced in the US, processed in Italy and manufactured/marketed in Spain. Tracking this process and working with several countries for one product can create unforeseen issues. In order to maximize efficiency, all of those barriers have to be surmounted and that is always at the forefront of our officers’ concerns.
What skills do you think are imperative to be successful in the role of a compliance officer?
One of the most important characteristics you need to have to succeed in compliance would be being a team player. This sounds like a very ‘soft skill,” but I cannot overstate how crucial it is to have good communication skills with not only your internal team, but to be able to have a direct and concise line of communication to the global affiliates that you need to deal with on a daily basis to ensure a smooth and timely launch.
Another characteristic needed to excel in the industry is organization/time management skills. I am more often than not working on several different tasks and projects every day that need to be completed in a timely fashion. The last trait that would be advantageous would be being detail-oriented; almost every project that I am involved requires such specific measurements that even the smallest typo—one letter or one decimal place out of place—can cause large delays in bringing product to market or even FDA audits.
Has there been anything that surprised you about working in compliance? Or that you didn’t expect when you began your compliance career?
The first thing that I was surprised about as I gained experience within the compliance industry was the extent that the products of Abbott and other companies like it have to go through to be fully regulated and able to be exported from the US, and even more so in attaining approval to be marketed in the U.S. This is a specific example that stuck with me, but the typical Band-Aid is so commonplace in our culture, and seems to be such a simple, standard product. However, a Band-Aid is technically a “medical device” that needs to be highly regulated! So if producing a Band-Aid requires adherence to such stringent regulations, you can imagine that the amount of regulation required of types of diagnostic machines that are able to diagnose patients with different diseases. However, I have been impressed each day with how important such regulations are to protect the users of any product.
One piece of advice for those interested in pursuing a compliance profession?
Compliance—especially healthcare compliance—is a great field to be in because it’s a field that will always be growing and maturing as new laws and regulations evolve. Whether an individual is coming from a law program, a sciences background, or whatever have you, there will be traits that each background can immensely contribute to a compliance division. The variety of background constitutes an integral part of any compliance team; for instance my team consists of biologists, PhD’s, attorneys, business majors, and engineers—all are needed to form a well-rounded team and to be able to get the products properly regulated.