Go to Client Portal

Carol Buchert

Senior Manager, N.A. Regulatory & Quality Consulting

Reserve your Consultation with our Experts

Contact Us

Carol Buchert has over 25 years of experience in the medtech industry. She was formerly President, Co-Founder and Co-Owner of a medtech business that successfully sold in 2015. Carol joined NAMSA in 2016, where she continues to manage the U.S.-based regulatory and quality consulting teams, providing regulatory affairs/quality assurance (RAQA) services primarily to North American, European, Japanese and Chinese markets.


  • Extensive experience in clinical diagnostics, in vitro diagnostics (IVDs) and medical device-encompassing diagnostic testing, research and development, product development, manufacturing, quality and regulatory affairs
  • Leading and managing quality, regulatory affairs, manufacturing, sales and marketing, business development and customer service within the IVD and medical device industry
  • Experience with clinical studies for Class II IVD products and clinical studies for Class II biologic/medical devices
  • Establishing, implementing and managing all aspects of quality systems
  • Managing the development and clearances of IVD and medical device product 510(k)s and device master files
  • Authoring and managing regulatory submissions through approval processes in India, Singapore, Taiwan, Malaysia and Israel
  • Managing medical writing teams responsible for authoring and revising Clinical Evaluation Reports (CERs) for compliance to MEDDEV 7/1 rev. 3 or MEDDEV 2.7/1 rev. 4 to MDD 93/42/EEC or MDR 2017/745
  • Managing in vitro clinical study activities, including protocol development, identification and contractual arrangement with clinical investigators/sites, Institutional Review Board (IRB) applications, product and documentation training, monitoring, investigational site interaction and report generation
  • Managing outsourced good laboratory practice (GLP) animal studies for primary and secondary stem cell engraftment as part of 510(k) submissions for biological/medical device
  • Managing product development/design controls processes, including customer and design requirements specifications, regulatory assessments, verification and validation
  • Conducting and managing external supplier and contract manufacturer audits
  • Hosting and managing multiple front room U.S. Food and Drug Administration (FDA) quality system inspection technique (QSIT) inspections
  • Conducting quality management system (QMS), Occupational Safety and Health Administration (OSHA) chemical hygiene, blood borne pathogen and safety trainings
  • Training laboratory personnel on testing methodologies and procedures
  • Participating in College of American Pathologists (CAP) and The Joint Commission (TJC) inspections in clinical diagnostic laboratories
  • Vast experience in immunology, serology, infectious disease, cancer, flow cytometry, cellular analyses, stem cell biology, cell expansion and characterization, cell separation technologies and cellular identification


  • Provided strategic guidance on developing and implementing QMS to Sponsors and their leadership in order to stay within budgetary and financial milestone constraints while ensuring regulatory requirements are met
  • Provided strategic guidance on regulatory pathways for various medical devices
  • Provided regulatory guidance on responding to FDA and Notified Body deficiencies