Kerri-Anne (Kerri) Mallet is the Vice President, Clinical & Regulatory Affairs for Pharmatech Associates, Inc., a full-service life science consulting firm. She has over 15 years of experience in fields of clinical, regulatory and quality within the life science industry. In addition to a strong background in medical devices, Kerri also has experience with combination products, in vitro diagnostic (IVD) devices, and biologically derived materials. Her background ranges from small and start-up companies to large multinational companies. Technological areas include cardiology, gynecology, urology, pulmonary, anesthesiology, orthopedics, otolaryngology (ENT), active implantable devices and general, plastic and robotic surgery. She has been instrumental in the successful application of various regulatory submissions worldwide, including, IDEs, PMAs, 510ks, De Novo applications, EU Design Dossiers and Technical Files for CE Mark, Canadian Medical Device Licenses (Class II – IV), and other worldwide submissions for countries such as Australia, Korea, Singapore, India, Mexico, Brazil, Saudi Arabia, etc. She has authored FDA Device Master Files (MAF), including one for a proprietary recombinant DNA biomaterial based on CBER guidelines, which has since been referenced in several successful 510(k) filings.
Prior to joining Pharmatech, Kerri ran her own consulting practice for over six years. During this time, she has developed her expertise in regulatory strategy and clinical development. Taking a cross-functional approach, she has advised clients on regulatory pathways most fitting to business objectives. She has interfaced with numerous regulatory authorities (FDA, Health Canada, ANSM, MHRA, BfArM, etc.) and Notified Bodies (BSI, NSAI, TÜV, LNE/GMED, DEKRA), and has assisted clients in their interactions with authorities. She has been actively involved in the creation and review of industry standards, regulations and guidelines through her past involvement in EDMA (European Diagnostics Manufacturers Association).
Kerri’s clinical expertise includes the development of Clinical Evaluation Reports (CER), FDA Annual Progress Reports (APR), investigation reports and systematic literature reviews. Using her knowledge of Good Clinical Practices (GCP), attention to detail and ability to identify critical parameters, she conducts targeted literature searches that avoid the need to review extraneous publications, and produces clinical reports that present all necessary data in a well-organized, easy to follow manner. Kerri has also been involved in protocol development for premarket and post-market clinical trials, and the preparation of clinical trial applications in the US (IDE), Europe and Canada.
She is also well versed in quality regulations. She has taught Operations Management for Northeastern University’s online MBA program and conducted numerous trainings on major quality system requirements, including Design Controls, Risk Management, Corrective and Preventive Action (CAPA), Supplier Evaluation and Qualification, etc. She has managed many FDA inspections and Notified Body audit. Kerri also has experience with crisis management and turning around quality systems that have been subject to warning letters and import detentions.
Kerri has a broad range of international experience. She has lived in worked in Austria, France and Switzerland and has traveled extensively throughout the world. She stays current on global regulatory changes through a variety of resources including industry trade organizations and a vast network of local contacts.
Kerri earned her Master of Business Administration from Northeastern University and is a member of the international business honor society, Beta Gamma Sigma. She received her Bachelor of Science degree (Summa cum Laude) in Biological Sciences with a concentration in Biochemistry and Molecular Cell Biology from Fordham University. She is also an active member of Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA).