Regulatory Mark has a clear mission: make the regulatory experience as simple and valuable as possible.
We deliver regulatory and quality services that expand your business and improve efficiency rather than just “checking the box” for compliance. Working with business owners and developers we craft customized solutions to your most complex regulatory challenges.
Regulatory Mark team Values a culture of excellence. Each one of our team members is devoted to using their knowledge and expertise to solve
problems and innovate.
Alison is an experienced Regulatory, Quality, and Clinical Affairs consultant for medical technology. With a background in Biomedical Engineering and more than 15 years working in Regulatory in the medical device field, she provides strategic consulting services to expedite products to market.
As an executive team member overseeing Regulatory and Clinical Affairs for 100+ employee company with domestic and international sales, Alison has been Regulatory lead for multiple product lines from concept and strategy through product release including regulatory submissions and FDA clearance/approval. She has experience with laser and radiofrequency energy devices, implants, sterile products, laparoscopic, cardiac, bariatric, orthopedic, general surgery, mobile medical apps, pediatric devices and aesthetic medical products. Her background includes IDE and NSR clinical trial strategy, management, and implementation. Areas of special interest include regulatory strategy for novel technology and working with entrepreneurs to implement efficient quality systems, manage risk, and bring new products to market.
In the past 5 years, Alison founded Regulatory Mark to work with emerging medical technology companies and startups to bring innovative products to market. As an organization, Regulatory Mark ensures that our deep knowledge of medical device regulation enables the development of safe and effective medical devices.
Colleen is a SoCRA Certified Clinical Research Professional with more than 20 years of experience in medical devices, in vitro diagnostics and pharmaceuticals. Her experience spans academia and industry including positions in the Office for Clinical and Translational Research at Cincinnati Children’s Hospital, CTI Clinical Trials and Consulting Services, Leica Biosystems and Aniara Diagnostica. Colleen’s roles have included Project Manager for multi-site clinical trials, Clinical Data Monitor for sponsor-initiated and investigator-initiated clinical trials, Consultant for the regulatory path to market for medical devices, Regulatory Lead for IRB, FDA and Health Canada Submissions and Director of Scientific Affairs responsible for regulatory and quality compliance. She has worked on projects in the areas of neonatal MRI, mobile medical apps for suicidality, spinal implants for scoliosis, kidney and liver transplant, coagulation and hemostasis IVDs, breast cancer diagnostics and pediatric migraine.
Colleen’s expertise spans the lifecycle of medical devices from first-in-human to post-market surveillance. Her primary area of interest is the operationalization of clinical trials that generate strong data for successful and efficient regulatory submissions. Colleen joined Regulatory Mark in 2019 to support entrepreneurs and their teams in their quest to move innovative products through clinical trials to market.
Agustina Susott is an independent Regulatory Affairs consultant based in Kufstein, Austria, with over 10 years of experience in the medical device, diagnostics, and pharmaceutical industries. She provides regulatory services to small and large companies wishing to market their products globally.
Agustina began her Regulatory Affairs career in the United States with a focus on first-time registrations and renewals for implantable vascular devices, and later expanded the scope of her work to include surgical products, imaging equipment for vascular access, in-vitro diagnostics, combination products for drug delivery, and SaMD in the USA, EU, Canada, Australia , LATAM, and APAC regions.
Her expertise beyond submission preparation includes regulatory strategy planning, new product development, risk management, product and manufacturing change implementation, quality management system implementation, audits preparation, and post-market regulatory compliance.
Agustina has collaborated with Regulatory Mark since 2018, contributing a global perspective to the team and their clients while bringing products to market.
Elizabeth’s regulatory and quality experience comes from over 10 years working for the FDA . As a Consumer Safety Officer conducting pre-market and post-market inspections of medical device manufacturers in the U.S., Europe, and Asia, she gained a deep understanding of medical device quality management systems. Elizabeth’s FDA experience extends to recall management, assisting companies through the corrections and removals process. Elizabeth was also an FDA Import Specialist with Import Compliance Officer experience, leveraging her comprehensive understanding of the FDA import entry review process including an in-depth understanding of Import Alerts and registration and listing requirements and exemptions.
Elizabeth joined Regulatory Mark in 2019 to bring her firsthand knowledge and FDA experience to industry. As an experienced auditor, Elizabeth collaborates with clients to evaluate and enhance their quality management systems in preparation for compliance with ISO 13485 and 21 CFR 820. She enjoys partnering with clients to proactively implement quality management systems that are fully compliant and meet the unique needs of each business.
As a career Quality professional with over 30 years in the medical device industry, Ruth Barnett has a proven track record. Ruth has been certified by the American Society of Quality (ASQ) as a Certified Quality Assurance Engineer (C.Q.E.) and Manager (C.Q.M.), and a twice certified as a Johnson & Johnson Six Sigma Black Belt.
In a 23-year career with Johnson & Johnson, Ruth implemented Quality Systems, and lead the growth of External Operations and Acquisitions & Integrations, including disposable, reusable, electro-mechanical device systems, and combination drug products. As part of a major business divestiture, Ruth orchestrated the Quality & Regulatory Affairs project plan for the transfer of $270 MIL business between six operating companies to become the new entity.
Her post-J&J career expanded the breadth of her knowledge into totally vertically integrated product mix of Active Medical Device Systems, infusion pumps, Drug Products & Nutritionals, Accessories, Kits and Product Labeling.
Ruth joined Regulatory Mark in 2018 to continue doing the work she loves, and to help teach a new generation of entrepreneurs how the implementation of sound Quality principals provides real value to their businesses.
Leila is a medical device development scientist, a chemical engineer (PhD), and a certified project manager (PMP), with over 9 years of research experience in biotechnology in academia and the private sector. Her interest in optimizing quality and efficiency in the life cycle of therapeutic/biotech products from research to launch drew her in regulatory affairs. As a scientist, Leila has strong technical and professional expertise in the field of biotechnology as well as familiarity with domestic and international regulatory guidelines ensuring the delivery of high-quality projects on time.
Leila joined Regulatory Mark in 2018 to use her technical background in the field of medical devices and facilitate the commercialization of safe and effective products and services. Areas of interest include US and international product registrations, post-clinical and post-market regulatory compliance activities for domestic and international products, and analysis of FDA and international medical device regulations for impact on novel products and regulatory compliance procedures.
“Quality is never an accident. It is always the result of intelligent effort.” – John Ruskin
Our process is transparent, collaborative and focused on making an impact. Through our work, we embody the following values:
Want to join Regulatory Mark?
If you’re confident that you’d make a great addition to our team, send us your resume. We’ll keep you in mind for future opportunities.