Michelle Lott RAC

leanRAQA

Since 2010, Michelle Lott has been on a mission. A mission to help smaller companies with all things regulatory – strategy and planning, regulatory submissions, audit preparation and remediation, due diligence, quality systems, and more. Topics that many companies view as unwelcome burdens and expenses to be borne as part of any healthcare, cosmetic or edible product’s go-to-market plan.

But Michelle’s approach is different. She wants to make her clients understand that a strong regulatory strategy can be a huge competitive advantage – and quite possibly fun. Her marketing strategy has been to flavor her extensive knowledge with a hint of sarcasm and a touch of humor, making her social media campaigns both informative and memorable. Because she understands how challenging quality systems and regulatory compliance can be, she has also marketed herself as a regulatory grief counselor, ready to help clients through the emotionally draining process of dealing with audits, inspections, and submissions.

After graduating Magna Cum Laude from Troy State University in Alabama with a bachelor’s degree in chemistry, Michelle started her career in regulatory and quality affairs working as an R+D Documentation Consultant for a small company in her home state of Mississippi. During that tenure, she became certified as a Quality Auditor by the American Society for Quality and leveraged that to win an Internal Quality Auditor role with Baxter Healthcare.

Lifestyle changes led Michelle to the desert Southwest where she truly began to develop her regulatory expertise. She took on a role as a Quality Systems Engineer for a healthcare device manufacturer, and soon discovered that there was no compliance culture or acceptance of quality management within the organization. Leadership viewed all regulatory and quality requirements as evil and unwarranted government-imposed, making the development of a company-wide compliance and quality management system much more challenging. The new role was demanding and the environment toxic, but Michelle had found her niche and continued to hone her craft. After just five months with the company, leadership recognized the contributions she had made to the company by promoting her to Regulatory Affairs and Quality Assurance (RAQA) Manager.

Michelle was then tasked with resolving an ongoing regulatory problem that had been languishing with the FDA for six years. Determined to fix the problem and move the company forward, Michelle started her investigation by reading each and every FDA-issued guidance document that pertained to the company’s products in order to understand the nature of the problem and what needed to be done to resolve it. The company had a lot of products, which meant there were a lot of documents to read, but all this in-depth research uncovered an unknown talent. Michelle had the ability to read, understand and – best of all – interpret lengthy and deeply detailed FDA documents and standards and transform complex regulatory language into straightforward statements and clearly-defined action plans that were easily understood. This previously hidden talent would prove to be the foundation on which her professional future would be built.

As Michelle continued her investigation into the company’s long-standing regulatory bottleneck, she attended a conference where an FDA panel was speaking on medical device regulations. Michelle took a seat in the audience and, to the astonishment of the other attendees, stood up and very bluntly asked the panel of FDA experts some pointed and specific questions about the regulations and how to resolve her employer’s issue. Having someone speak so plainly and directly to the FDA was unheard of at the time, but her persistence, depth of knowledge and clear understanding of the regulations caught the attention of not only the FDA panel but members of the audience as well. Not long after that conference, Michelle was approached by a manufacturer with a need for her expertise, and her regulatory side hustle was born.

Even as her side hustle began to gain momentum, Michelle’s achievements were acknowledged by her employer, and she was promoted again to Regulatory and Quality Affairs Director. Even with this new and challenging position, Michelle continued to foster her fledgling business, taking calls from potential clients on her lunch hour and working nights and weekends on their projects, often using paid time off from her director role to meet with her private clients face-to-face.

Almost without knowing it, Michelle had started a business with the potential to become a full-time endeavor. This part-time business provided an outlet for her creativity and unique problem-solving capabilities while setting the stage for her separation from the device manufacturer and its toxic lack of support for any real quality management culture. She maintained this double life for several years until one spectacularly bad day, when lots of anger had been unfairly and incorrectly vented in her direction, Michelle handed in her notice to the device manufacturer, effective immediately. On her way out the door, she received a call from another potential client, and never looked back.

Michelle founded her company – LeanRAQA LLC – with the intention of putting her twenty years of healthcare product experience to work helping emerging companies navigate byzantine regulatory requirements and to appreciate the value of a strong quality system. By providing uniquely simple solutions to complex regulatory challenges, Michelle has distinguished herself in the industry as someone who can Make Quality Make Sense™, improving a client’s bottom line while making much-maligned quality and regulatory compliance processes almost enjoyable.

Michelle has supported over 100 companies with regulatory strategy and submissions, audit preparation and remediation, quality systems compliance, due diligence, and technical support services. She served a term on the FDA’s Device Good Manufacturing Practices (CGMP) Advisory Committee, providing strategy and guidance to the FDA on key healthcare industry topics, and in 2013 graduated from Northwestern University’s Kellogg School of Management Regulatory Affairs Professionals Society (RAPS) Executive Development Program. She has served as a regulatory participant in the Global Enteral Device Supplier Association (GEDSA) and has been a member of The International Consortium on Systems Engineering (INCOSE), serving as sub-team lead for their Model Based System Engineering Healthcare Working Group.

But Michelle is not all work and no play. She and her husband share a house with four dogs – the LeanRAQA Dream Team featured prominently in her social media posts. She has a Southerner’s deep-rooted weakness for anything barbecued and a taste for tequila nurtured during her time in Arizona and New Mexico. When asked at parties, Michelle’s fun fact is that she served as an expert witness in forensic toxicology for the Mississippi State Crime Lab.