Brandy G. Robinson
Regulatory Affairs & Compliance Executive
Highly proactive professional with an insatiable nature to capitalize on opportunities and tackle new challenges. Diversified expertise in legal, compliance, and regulatory standards. A cross-functional global team leader, excelling as a public speaker, higher education lecturer, student advisor, and faculty mentor.
November 2021 to September 2022
Head Of Regulatory Affairs & Compliance
Handled all regulatory, compliance, and governmental interactions. Drafted, reviewed, and prepared 510k filings and other reports with the intent to submit for approval to different jurisdictions where submission for registration is required. Transitioned regulatory compliance of products from IVDD to IVDR (CE-Mark). Assessed the company's compliance needs, essential principles, and good manufacturing, laboratory, and distribution practices.
February 2020 to November 2021
Quality Assurance Manager
Led the global quality department and ensured the company’s functionality across countries. Revised company processes to meet Food and Drug Administration (FDA), Federal Trade Commission (FTC), Good Manufacturing Practice (GMP), and Hazard Analysis Critical Control Points (HACCP) regulations. Analyzed quality data, including analytical and microbiological results. Drafted and maintained standard operating procedures (SOPs), quality, and regulatory documentation, including label compliance (NLEA) across federal regulations (21 CFR 101 & 21 CFR 111) for nutrition and packaging.
February 2018 to February 2019
Regulatory Affairs Officer
Performed regulatory risk analysis and mitigation for two international companies. Directly responsible for licensing and compliance. Drafted compliance documentation, reviewed vendor contracts/agreements, and vetted potential vendors. Liaised with multiple internal departments and companies to ensure the best customer experience. Managed and maintained quality assurance processes and compliance documentation for FDA and rest of the world medical device compliance and audit. Performed daily inventory adjustment audits for product traceability and logistical and regulatory purposes.
October 2010 to September 2017
President & Principal Consultant
Assisted entrepreneurs and businesses in the early stages of business development. Guided companies in strategic development. Accelerated new market placement through research and competitive analysis. Provided guidance on legal, regulatory, training, licensing, and compliance best practices to enhance business efficiency and profitability.
October 2003 to July 2004
Assistant City Attorney
Handled prosecution and jury trials, screened and negotiated cases including but not limited to matters involving police liability, premise liability, consent agreements, labor and employment law, and more. Assisted city officials and staff with legal and regulatory issues. Drafted various legal opinions, memorandums, and reports with recommendations. Served as a representative on city committees, including the Flint Historical District Commission.
September 2003 to Present
Adjunct | Associate Professor | Lecturer | Student Advisor Faculty Mentor | Course & Curriculum Developer
Facilitate class instruction and lecture on a variety of subject matter areas ranging from liberal arts, university studies, legal studies, healthcare, ethics, business and English as a Second Language (ESL) at various universities. Provide curriculum and course development. Review and assess curriculum objectives and outcomes. Compile, interpret, and analyze data and reports. Review and approve student journal submissions. Serve as a course lead, co-editor, and mentor to student writers for student publication.
Brown & Stanley, PC
November 2002 to August 2003
Prepared and drafted legal documentation for clients (motions, complaints, reports, letters, agreements, and briefs). Interviewed and prepared clients for hearings, meetings, depositions and trials. Researched and examined case law and statutes. Evaluated research, development, and settlement stages in complex litigation.
Reactivated the company's QMS processes and systems and utilized Six Sigma methodologies to optimize, yielding an average cost savings of approximately $200K in quality personnel staffing.
Recovered $1.2M in quality-related claims and chargebacks through contract manufacturer non-compliance.
Saved the company over $500K by consolidating staff responsibilities and reallocating resources of in-demand technical roles.
LEGAL & COMPLIANCE
REGULATORY STRATEGY & OPERATIONS
INTELLECTUAL PROPERTY & LICENSING
SMALL BUSINESS SUPPORT
Juris Doctor (JD)
Manuela Herde, Purchasing & Production Manager, Celsius, Inc.
I had the honor and privilege to work with Brandy in a fast-paced manufacturing setting for numerous years.
In her role as Quality Assurance Manager, she worked closely with our Purchasing and Manufacturing team. We valued her in depth knowledge and experience in the field of quality and regulatory and to uphold all internal and external quality systems. In my experience, there are not many people who are able to hold up under severe pressure to consistently deliver quality results as Brandy does. She is driven to succeed, has a very strong work ethic and is eager to apply her knowledge practically. Brandy is a valuable asset to our team and any future team.
It is with great pleasure that I write this letter of recommendation on behalf of such a deserving candidate.
Chad Apuli, Director of Product Development, Co-Diagnostics, Inc.
I worked with Brandy at Co-Diagnostics, Inc. where she worked as the Head of Regulatory Affairs and Compliance. Brandy and I worked closely on multiple projects including preparing the company for our ISO audit and working on regulatory submissions for various products.
As soon as Brandy started working with the company, she immediately jumped into the fray and began by diligently working to assess the company and identify any gaps in our quality management system (QMS) and the related processes. Brandy is extremely hard-working and was able to identify a variety of issues within our system and processes. Brandy worked with the team to ensure that the issues were addressed within the QMS. She motivated the team to take the necessary actions to correct and prevent these issues from occurring in the future by addressing the root causes. Brandy is very knowledgeable, and we used her as a resource to help us better understand the relevant regulations.
For these reasons and many more, I recommend Brandy as I believe she would be an indispensable resource for any organization willing to give her the opportunity to join their team.
Peggy Ruscitti, Adjunct, Broward College
I met Brandy through one of my students. I teach project management. I mentioned my desire to teach online. This student said that Brandy would be happy to share her experiences and knowledge. Brandy and I met and I consider her a good friend as well as a mentor. Brandy shared information and experiences that has helped me pursue a career teaching online. Through our conversations in person and online, I see how Brandy is a servant leader who will finds ways to help her people improve to complete current and future tasks on a timely basis with high quality.
Joslyn Baker, AFSCME Local 88 President and Project Manager,
Multnomah County Department of Community Justice
I have been impressed by the wide variety of Brandy’s skills and talents. She is enthusiastic and visionary in how she approaches challenges and projects. This, along with her strong interpersonal skills, helps her engage people and collaborate with others. She is reliable, dedicated, and focused in her work. Brandy is a problem solver and will be a great addition to any company that hires her.
Sandra Oberdorfer, Artist, Carrot Flower Creative
I've known Brandy Robinson for several years, in both professional and informal environments, and know her to be a thoughtful, generous, and reliable person to work with and be around. In particular, Brandy and I volunteered together as members of the Portland Chapter of Women's International League for Peace and Freedom, in which she served as Co-President while I served for a time as Membership Chair. Brandy's work with Portland's WILPF brought the organization to new audiences and widened the scope of the chapter's positive influence within the community. She'll be an asset to any company who seeks to hire her.
Shelley Lacerda, CEO / Executive Producer, CDN Broadcast
I know Brandy to be a self motivated problem solver who has worked for us on several important projects over the years.
She has held positions of assistant producer where she has been in charge of securing location permits, organizing staff and managing camera crews. She has also been a contestant coordinator who worked directly with cast members from 15 different countries. She trained the staff for each event and has consistently demonstrated high standards for quality, accuracy and productivity.
Her latest role with our company has been as events & project manager which encompasses all of her previous roles plus overseeing the budgets; approving the marketing strategies and organizing schedules. Brandy supervises the entire event from start to finish.
She is an asset to our company and takes imitative to go beyond the expected parameters of her job. Everyone here at CDN Broadcast is very grateful to Brandy for her contributions to the success of our events. I am confident that she has the intelligence, work ethic and professionalism to add value wherever she goes.
Mary Hanson Harrison, President, Women's International League for Peace & Freedom (U.S.)
Brandy was co-president of the Portland, OR Branch of the Women's International League for Peace & Freedom US Section (WILPF US). WILPF was founded in 1915 at The Hague and continues to serve as the longest-lived women's peace movement in the world. We have offices in Geneva, Switzerland/New York/Iowa and have consultative status at the United Nations.
Professionally, Brandy's leadership and speaking ability added to the successful completion of events and projects taken on by the WILPF Portland Branch. Among her many other abilities, she has the experience and patience to deal with differing opinions in a constructive manner. No small feat when dealing with a large group of women with differing opinions!
Personally, I found her to be a good friend and offered sound advice when needed.
Natasha Beck, Co-President, Women's International League for Peace & Freedom
(Portland, Oregon branch)
Brandy and I served as co-presidents of the Portland branch of Women's International League for Peace and Freedom. Brandy showed excellent leadership in her ability to follow-through on commitments, collaborate with many other organizations, plan and chair meetings, mediate conflicts, recruit members, and advocate for women and people of color.
Gail Harriott, Senior Technical Program Manager, Amazon Web Services (AWS)
Brandy is one of the hardest workers I've ever met. She is innovative, creative in her thinking and is always seeking the best solutions to a problem. I have no doubt that she will be an asset to whoever is fortunate to employ her.
Q & A
Why did you choose your profession?
I found this profession to be a great merger of my education and experiences and I really nerd out when it comes to regulatory. In fact, in law school, I excelled in my electives that related to regulatory law, business planning, and corporation law. Like most law students, we think we will go into practice, likely litigation. But, my trajectory was a bit different. I did not know it then but somehow those electives would pay off nicely in my future regulatory profession.
Back then, I knew I did not want to practice law as practicing law definitely wasn’t fun (no matter the area of law, sector, or role), and I saw so many people who changed (and not in a good way) after becoming an attorney. I was fortunate to have some very smart people around me who got it and showed me there was more to the law degree than practicing law. I was able to understand the law degree was more valuable outside the law than inside the law.
I worked throughout law school as a night auditor for Courtyard by Marriott and frequently met lots of professionals in a variety of industries. I was fortunate to cross paths with governmental officials, executives, and even celebrities, who unknown to me, were watching and observing my work ethic and respected that I was earning my way in my career. To my surprise, some of these people provided unsolicited advice; some even wrote unsolicited recommendation letters for future jobs, after I graduated from law school. I took that advice and during my law school experience, I gained as much experience in a variety of roles. I interned for a Michigan State Representative (Jim Howell), later externing at Thomas M. Cooley’s Sixty Plus Elderly clinic and then externing for a federal district court judge (the late Avern Cohn) in the Eastern District of Michigan (all while attending law school full-time and working full-time at night).
After law school, I took the traditional path in seeking out associate jobs (again, as a way to ‘tick the box’ thing for that traditional law practice experience). I worked for a long-standing African American law firm (now closed) and later I worked under the famed, super lawyer, associated with the O.J. Simpson Dream Team, Lynn H. Shecter. Those were wonderful experiences. I learned a lot about practice, such as being a great legal professional and utilizing legal tricks, concepts, theories, rules, and strategies that are often forgotten about or underutilized that is not easily acquired through any law experience. I cannot forget about the valuable insight I learned about practice in being a minority member in law, including being a woman in law and how to strongly advocate for myself as a woman in law and in bringing other diverse aspects of myself into the fold, which aspects have relevance today in infusing broader acceptance, diversity, and inclusion into the profession.
Yet, I knew that the law practice was not where I saw myself. Some people think that because you attend law school that the only thing you can do is practice law (and if you are not practicing law, you are somehow less than); some people do not understand there is more to life with a law degree than practicing law. Instead, I taught law for many years, while offering business consulting services to startups and nonprofits, as it provided me with the best work-life balance. It took me sometime to navigate into the regulatory field since it was still a relatively new field for most companies and professionals. But, that’s how I navigated into the field.
Even today most companies do not know what they want in a regulatory professional. There are ads asking for scientific degrees, since many companies believe this is necessary and the only path in the regulatory field due to the products being developed and the technical know-how (i.e., they feel they can best navigate regulatory mine fields). But regulatory affairs is really a legal-regulatory field. There’s a lot of spaghetti involved in the regulatory sector and it is not an easy as reading and understanding a regulation; if you do not have a legal background, that spaghetti can become very complicated, really fast and the companies lose traction and may be exposed to many legal-regulatory blind spots and risks that those who do not have that legal expertise would fail to appreciate.
Now the why I chose this profession is simple: The regulatory profession is where I nerd out as my legal expertise and other competencies like my Six Sigma Master Black Belt and my MBA in International Business Management and Marketing and my LLM in Transnational Law merge and comes in handy. Because of this combination of experiences, skills, and education, the way I think is different, providing an edge for companies and the know-how in quickly learning even the most complex concepts and processes.
How do you approach bringing new, big ideas and transformation to an organization?
There are several approaches I use, but two approaches dominate and have proven to be the most successful in presenting new, big ideas and transformation to an organization: Cognitive Load and CEO Buy In.
Cognitive Load Approach: The educator in me knows and understands that most people cannot digest or retain large amounts of information and not all at once. The Cognitive Load Theory supports this, which states that smaller chunks of information and use of varied learning formats work best. Following this method helps in gaining buy-in from those who would make the final decision on that new and big idea or transformation being presented. In my approach, I condense information into understandable, small bites of information. I introduce these ideas early in guiding others and in offering expertise on a particular manner and in different ways (it could be through use of a diagram, chart, mnemonic, or relation to real-time and real-life examples).
The reason why understandable, bite sizes of information work best is that when information is not presented in a simplistic manner and overload occurs, your intended audience could have one of several reactions or behaviors. This could be either: (1) a lack of recall of the information (2) the information is complicated (3) the information is confusing (4) the information feels untrue or (5) the information seems confusing. So, as a general rule, when presenting data (even data that is extensive or has numerous data points), the information must be simple, short, and understandable to the lowest average reader level. While this reader level could be typically a 7th-grade reading level for the average adult, presenting the information at an even lower reading level would be better for obvious reasons.
CEO Buy In: The best and most effective way is to get the CEO’s buy in. This approach has helped me tremendously in my career. Plus, I gain valuable insight on the overarching strategy for the company through CEO feedback. If you do not have this buy-in, you likely will face a more complicated route in getting the idea or transformation approved as there will be a lot of internal and unnecessary politicking on the ideas.
Before you gain the CEO’s buy-in, it is important to do the research, be thorough, and gain other perspectives, since your perspective isn’t the only one. No one knows everything and we must constantly audit ourselves. This meant that I regularly sought out other perspectives to make sure I was not missing something or to see if there were other viable and effective ways in doing the same thing or in getting a similar result.
In my role as Quality Assurance Manager at Celsius, Inc., my expertise ranged from legal, quality, and compliance to regulatory. I always had an open door with the CEO (John Fieldly), where I provided insight and quality-related opinions for the overall effectiveness and compliance of our Celsius products. John also frequently sought out my quality perspective. He liked to be equipped from all angles. So, once he understood the various moving pieces and what was appropriate from a quality perspective, he provided his feedback and approval and was known to say ‘get it done.’ I appreciated his leadership since his leadership was tough but compliant. With John’s buy-in and through the quality function, we were able to recover nearly $1.2 million dollars. I knew I had a partner in John to push forward appropriate quality principles and processes.
In my role as Head of Regulatory Affairs and Compliance at Co-Diagnostics, Inc., I lead cross-functional teams on global regulatory strategy and operations. In our management meetings and executive roundtable meetings, I regularly met and interacted with the CEO (Dwight “Ike” Egan) as well as with other executive members. When I reported for the Regulatory and Compliance Departments, my opinions were necessary in order to consider the bigger picture and forward-thinking principles, i.e., those aspects not yet thought about, which forced departments to think outside the box and create solutions in order to meet those regulatory and other compliance standards.
Ike also sought out my regulatory and compliance insights, calling special one-on-one meetings to discuss current regulatory development and regulatory strategy. When it came to regulatory oversight and input, he was vocal and supportive in executive meetings in allowing space for those regulatory and compliance inputs, which provided more rigor in our device design and development process while leaning into that process with integrity. Through my leadership in the Regulatory Department, if the device did not clear internal regulatory scrutiny, Ike knew that the device was not ready. At Co-Diagnostics, I knew that Ike appreciated and respected my expertise and regulatory opinions.
How has integrity played a role in your work life?
Integrity is really about character and that is really all we have. A person’s character is demonstrated over a lengthy period of time. Integrity is also a huge part of how I think and operate in any work environment. Further, when I look to either hire direct reports or choose what company I would like to work for or with, I look at character, as it can be quite telling in many ways. If you hire or choose correctly, there would be little concern relative to integrity and following the rules, and focus can be shifted to goals and outcomes.
My legal experience and background mandates that I act with integrity. We are taught and trained in law that everything we do must be done with integrity and consistent with ethics. It goes to professional liability and in making sure we advance the time-honored values of the legal profession. This is something I do take very seriously, which is why I am a rules follower.
It is important to distinguish that ethics and integrity can be viewed as two different things (one of which is internal and the other as external). However, I view these as one in the same. If you are not doing one versus the other, clearly at some point, this can cause conflict and become quite confusing and inconsistent. The law of contradiction supports a similar line of thinking, i.e., a thing cannot be both true and false at the same time.
To make this clear, no one is perfect (I am including myself into this as well). Yet, I follow the belief system that we should strive each day to achieve the highest level of personal and professional integrity as much as possible. We do not get a special award for doing such and no one is watching us, counting how many times we are behaving within the lines. However, we should act in a way where our closest confidant would feel proud that we did the right thing.
Let’s take procedure as an example, as this is an area where integrity meets ethics. I can provide numerous examples of attorneys, who did not follow the rules and were subsequently suspended or disbarred, which are great examples where integrity meets ethics. And these things were simple legal ethical requirements such as the ethics of client trust accounts.
I learned early in my law school education that ‘procedure is your friend.’ I love this phrase because this is very true and applicable to virtually everything in the legal profession. The risks are simply too high to not follow the rules, as illustrated above.
While there may be gray areas where certain procedures or rules do not have to be strictly followed, not following those procedures or rules could cause more harm and unnecessary increased risk for the client. This goes to both integrity in how the professional navigates that process and the ethics in whether to follow the rules or not.
My regulatory experience also mandates I act with integrity. You cannot escape integrity. It is virtually everywhere in the regulatory function and must be taken seriously as the buck usually starts and stops at the regulatory professional, no matter the point in the design control process. I am a rules follower and this has been something appreciated by my employers. They have confidence in knowing I will do the right thing, as they never had to think twice on my work.
One of the biggest responsibilities of a regulatory professional is serving as a liaison between the regulatory bodies and device manufacturer. Everything from regulatory meetings to regulatory communication (both written and oral) to regulatory submissions require ethical rigor and finesse. Not everyone can act with such. The regulatory professional may have competing interests in getting a device registered quickly and ready to place onto the market for sales and approving an efficient design that is safe and effective while keeping to regulatory and compliance standards.
Though there are gray areas in the regulatory field, if the regulatory professional isn’t following the rules, it will be uncovered. There is no place to hide in the regulatory field. For instance, when a device is designed, developed, manufactured and/or registered with a regulatory body (for instance, with the FDA via a 510k, De Novo or PMA), a regulatory professional is attesting that the device complies with all applicable regulations and requirements, is safe and effective and no information has been hidden or missing from the regulatory submission. My experience successfully interacting with entities like ANVISA, FDA, COFERIS and InDRE, TGA, MHRA, Health Canada, European bodies, DIGiMED, SFDA as well as notified bodies and certifying standards organizations (ISO and MDSAP) tells me that being transparent and providing the necessary information to support regulatory requests (and not cutting corners) are tantamount to showing that the device has not only met the requisite standards but is a safe and effective device to place out into the designated market.
This goes without saying but I will not sign a regulatory submission if I believe it is either not complete and accurate, the regulatory mandates have not been fulfilled or it does not demonstrate that all regulatory mandates have been satisfied, as the device is not ready to be put into the market. It is a legal obligation and must be taken seriously. I believe in the motto of ‘measuring twice, cutting once.’ It is better to do it right the first time than put a device into the market when it is not ready, where there are known and unknown consequences, issues ranging from warranty, device safety, device security issues, brand and reputation damage, as well as various regulatory issues, the list can go on.
What tools do you use?
There are a variety of tools I utilize, that spans beyond the basic Office Suite of applications and online conferencing tools (like Zoom, Teams, Skype, Google Meet, Cisco Webex, and GoToMeeting), but align best with my certifications as a Six Sigma Master Black Belt, Lead Auditor (ISO 13485) and Project Management Professional. The key to effective tool utilization is knowing what tools work best for certain tasks and outcomes, as not all tools can be used effectively to generate the intended outcome. In essence, some tools work better for certain tasks than other tasks.
Besides the typical Google Office products and Microsoft Office products (like Word, Excel, PowerPoint, or its Google equivalence) and various online conferencing tools, the following tools and systems are utilized:
(2) Root Cause Analysis (5 Whys, Pareto Charts, FMEA, Fishbone and Scatter Diagrams)
(4) Various Six Sigma and Lean Principles
(5) Greenlight Guru QMS
(6) QT9 QMS
(8) SWOT Analysis
(9) Voice of the Customer (VOC)
(10) SMART matrix and goal setting
(12) Value Stream Mapping
(13) Process Mapping
(14) Various diagrams, control charts, and flowcharts (including Gantt charts and brainstorming techniques)
(15) Analysis Models (including risk analysis models, e.g., SWIFT, Delphi, decision tree, probability matrices, etc.)
(16) Microsoft Project
(19) LexisNexis, Thomson Reuters (including Westlaw), Fastcase, and Bloomberg (including Bloomberg Law)
(24) Oracle NetSuite
(25) Collaboration software (Teams, Sharepoint, Google Workspace, and Slack)
(26) Online learning platforms (Blackboard, Canvas, Moodle and Schoology)
(27) Graphic design software (Adobe (including Photoshop), Lucidchart, Canva, Microsoft Publisher)
(29) Country specific and regional regulatory databases (FDA Industry Systems, MedWatch, EUDAMED, MHRA DORS, etc.)
(30) Profit and loss models and budgeting tools