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.

CORE COMPETENCIES

• 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

RECENT PROJECTS

• 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