20+ Year RAQA Master;
Our CEO: Chief
Morty is perhaps the best-known member of the lean RAQA team, having been the inspiration for a number of Michelle’s more successful LinkedIn posts. No matter the topic, our chief entertainment officer always finds a way to make regulatory affairs interesting, even if it does mean sacrificing his dignity and posing upside down with his paw placed uber-dramatically over his eyes whenever new regulations are released.
Upon joining the team three years ago, Morty quickly established himself as a source of endless amusement and worked his way steadily up the ranks from pool monitor to lap warmer to Chief Entertainment Officer. Morty is a true self-starter, teaching himself not only how to get in and out of the pool on his own but also how to dry himself off before heading back to work. It is just this type of initiative that earned Morty his promotions, and his dedication to keeping the lean RAQA team entertained will no doubt keep him in the CEO chair for quite some time.
Our CTO: Chief
Lucy takes her Chief Therapy Officer responsibilities very seriously, and spends her days closely monitoring the moods of the lean RAQA team from her perch on a carefully selected lap. If she senses a darkening mood, Lucy is quick to take action, skillfully diverting attention from the screen and keyboard by repeatedly licking the patient’s face. These tactics have been shown to effectively prevent a total nervous breakdown on more than one occasion.
Lucy also has a reputation for being something of a drama queen when necessary and is especially well-known for draping herself over Michelle’s keyboard in an attempt to divert regulatory tensions from escalating. This iconic photograph has garnered a lot of attention since its publication in 2017 and serves as an ongoing reminder of why Lucy is such a valued member of the team.
Our CFO: Chief
Chopper may only have three legs but that hasn’t stopped him from fully embracing his responsibilities as Chief Fun Officer for the lean RAQA offices. Chopper is often the instigator of any office shenanigans, playfully nipping an ear to cajole his canine colleagues into a midday wrestling match or barking at imaginary threats to initiate a three-part flash-mob chorus. Quick to sound the alarm should an unamusing intruder appear, Chopper is ever alert for any threats to his mandated daily fun and games. He knows the importance of a work-life balance and is always on the lookout for someone in need of a serious play session. When not patrolling the office for opportunities to make someone laugh, Chopper can be found on the doggie bed, serving as mattress and pillow for Morty and Lucy.
RAQA Whiz and Grief Counselor-in-Training
Ti has nearly 10 years of experience in medical device quality assurance and regulatory affairs. She began her career as one of six employees at medical device startup designing products for the radiologic and ophthalmic spaces. Since then, Ti has developed a proven track record of successful quality management system implementations, quality audits and regulatory submissions for Class II medical devices.
Ti is passionate about improving patient outcomes, and her biomedical and ISO 13485:2016 auditor certifications allow her to help small and midsize companies bring safe and compliant products to market.
Ti graduated from the University of Arizona with her B.S. in Biomedical Engineering with an emphasis in biomaterials and continues to act as a professional mentor for the UA chapter of Engineers Without Borders.
Fun Fact: Ti is our grief counselor-in-training and is an avid gardener and chef who loves attending food, wine and beer festivals.
RAQA Guru; Intelligence Gatherer and Curator
Maria is a focused, driven, and passionate regulatory specialist with nearly 10 years of experience in medical device product development. She brings great depth of knowledge to the lean RAQA team, having earned a degree in biomedical engineering and a Master of Applied Science as well as her RAC certification.
Maria has played a strategic role in developing the market entry and compliance strategies of medical devices in various international markets. She has experience with a variety of international regulations, including Europe’s Medical Device Regulation (MDR), Australia’s Therapeutic Goods Administration (TGA), Health Canada, FDA, and others.
Her specialties include regulatory strategy and submissions, technical file development, Unique Device Identification (UDI) implementation and labeling design and review.
When not elbow-deep in international regulatory strategy, Maria is a passionate snowboarder and can often be found rocketing down a snowy mountain.
Fun fact: Kia Ora, I’m a French Canadian of German descent, living in New Zealand. Au plaisir!
Quality Assurance and Auditor Extraordinaire
Raines is passionate about building Quality Management Systems that extend a team's ability to get the right work done. He has been serving the medical device industry since 2014, and brings expertise in Quality Management System design controls, risk management, and software to the team.
Raines recharges through rock climbing in the Sierra Nevada, writing about personal interests, and listening to podcasts.
Fun fact: Raines is left-handed. It explains so much!
Laura comes to the lean RAQA team with a Master’s in Biomedical Engineering and more than six years of regulatory experience in the medical device and pharmaceutical industries.
She has done extensive work bringing non-prescription drug products to market through the FDA’s over-the-counter (OTC) drug review process. Non-prescription drugs approved by the FDA are granted an OTC monograph, which serves as the “rule book” for the drug’s release.
Laura also has expertise in FDA submissions of generic drug products, or abbreviated new drug applications (ANDAs). These submissions require no pre-clinical or clinical data to demonstrate safety and effectiveness, but must still show that the product performs the same way as the innovator drug.
Fun Fact: Laura has led a somewhat nomadic life and has lived in seven states and 2 countries.
SaMD, Electrical Safety, Imaging/Radiation Sensei
Jim came to lean RAQA after a circuitous career path. After a stint in the military, he decided to pursue a degree in nursing and spent the next ten years working in critical care and the cardiac cath lab. During his time in the cath lab, Jim was introduced to Phillips imaging systems and was later recruited by the company to train providers on the use of the Phillips system.
After several years on the road, Jim transferred to product development where he was able to focus his technical skills on the development and maintenance of quality system management documentation. While in this role, Jim found himself drawn to regulatory affairs, and eventually earned his Master’s Degree in Regulatory Affairs.
When Phillips closed their Florida office, Jim leveraged his twenty years of medical device regulatory experience and became a consultant. Shortly thereafter he met Michelle and was immediately drawn to the professional but fun approach she brings to quality and regulatory affairs.
Jim’s specialty is electromechanical software driven devices with a particular passion for Artificial Intelligence/Machine Learning imaging devices.
Fun Fact: Jim started his career as a Sergeant in the Air Force maintaining the jet engines on fighter planes.
Biocompatibility and Sterility Savant
Esther has been with the leanRAQA Team since January 2020 and has been supporting activities for chemistry, biocompatibility, sterility, packaging, and stability/shelf life. She has been in the medical device/pharmaceutical industry for the past twenty years supporting manufacturing changes, material contact support for device and pharmaceutical applications, sterility assurance, and has developed analytical methods including supporting and conducting method validations for impurity analysis. She has been performing biocompatibility assessments for the past 10 years and has survived and thrived during the many changes to Standards and Regulations.
In her professional career prior to joining the leanRAQA Team, she has conducted biocompatibility and chemical/toxicological assessments, conducted short term stability testing for pharmaceutical drug products, developed potency and impurity methods for pharmaceutical drug products, and authored many SOPs, scientific protocols and reports, and risk assessments to qualify materials for their clinically relevant use. Esther’s strength is her technical experience and her motto “Compliance will catch up with Science” drives her to stay ahead of current regulatory trends. Esther is currently working on completing her Master’s Degree in Toxicology from the University of Michigan and loves to spend any free time with her family trying and testing new recipes.
RA Specialist and Southern Gentleman
Trey rounds out the lean RAQA team with 15 years of experience in regulatory affairs. His areas of expertise include managing the MDD-to-MDR transition and quality system development for the medical device industry.
Trey also has a history of successful of Class I, II and III device submissions, specializing in women’s healthcare, surgical capital equipment, active implantable devices, wound care, incontinence devices, and infusion pumps.
In addition to his RAC certification, Trey has a degree in chemistry from Millsaps College and a Master’s Degree in Pharmaceutical and Biomedical Regulatory Affairs from the University of Georgia.
Fun Fact: Trey has a well-known weakness for Texas BBQ, and spends his weekends hunting, fishing, and woodworking.
RA, SaMD, AI Sage;
John is a seasoned Regulatory Affairs Professional focusing primarily on project management and regulatory compliance within the Medical Device and Bio-Tech Industries. Hehas professional experience in Medical Device Regulatory Affairs, Connected Healthcare, Artificial Intelligence, and a vested interest in business development.
In recent years, John has been working with global start-up companies with breakthrough technologies with the aim to bring revolutionary healthcare solutions into the global market.
John's core expertise is bringing products from new product development to global market transfer and commercial release. He also excels at formulating strategies for regulatory submissions and in creating multidisciplinary teams to resolve regulatory hindrances. He works to ensure the strategic planning and preparation of FDA Pre-Submissions, Breakthrough Device Designation, IDEs, 510(k)’s, De Novo’s, PMA’s, CE Marking and international registrations. He also resolves regulatory concerns that arise via deficiency letters, product complaints, adverse events, recalls and oversee remediation activities to maintain regulatory compliance.
John has extensive professional experience working in various therapeutic areas including Dental Implants, Ophthalmology, Radiology, Cardiology, Endoscopic Technologies, Neurosurgery, Gynecology, Endo-surgery, Renal Therapies, and Diagnostic Devices. John has worked with small startups to fortune 100 companies including, DePuy Synthes, Ethicon, Fresenius Medical Care.
John has held leadership roles as the Director and Head of Regulatory Affairs within the industry as well as teaching roles in the academia. John was a university professor and director of the graduate Drug Regulatory Affairs program where he has taught candidates in the Masters, Pharm.D. and Ph.D programs Medical Device Regulatory Affairs.
Fun Fact: John enjoys hiking, biking, and spending time with his two munchkins – Christian and Christina – and the rest of the minion crew.
40-year RAQA Veteran; Food, Cosmetic, Device, and Drug Authority
Beth has 40+ years of experience in Quality Assurance, Compliance and Regulatory Affairs for FDA-regulated products. From diagnostics to pharma to combination products to dietary supplements to veterinary, Beth's done it all. She also has extensive experience with government agencies, state licensing and international regulations.
Prior to becoming a consultant, Beth served as Vice-President of Regulatory Affairs for 12 years at Medline Industries. She has also filled a variety of quality assurance and regulatory affairs roles for BD, Abbott Labs, Novartis, Dow, Lamaur, Kemin, and Qualis and has attended hundreds of conferences and workshops - the outcome of a long and successful career.
Beth has a B.S. in Chemistry, Microbiology and Human Anatomy and Physiology, and a Masters Degree and currently lives in Naples, Florida.
Fun Fact: Beth worked as a medical technologist and then attended medical school before focusing on regulatory affairs.