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Darlene co-founded Experien Group with Michael J. Billig. During her 35+ year career in the medical device industry, Darlene has directed over 300 successful submissions, including PMAs, IDEs, 510(k)s, HDEs, Technical Files and Design Dossiers. She has provided regulatory, clinical and quality leadership for a variety of products, including implantable cardiovascular pacemakers and leads, parenteral and nutritional IV solutions and administration sets, ophthalmic drugs, contact lenses and contact lens solutions. Darlene is an expert in validation testing, including sterilization (ethylene oxide, radiation, steam and dry heat) and aseptic processing.
At Experien Group, Darlene’s primary role is to oversee regulatory affairs, quality systems and clinical research activities. For several clients, Darlene functions as the Acting Vice President of Regulatory, Quality and Clinical, representing the companies in interface with regulatory agencies, investors, and more. She has developed a fully-customizable, comprehensive Quality Management System for Experien Group clients. Darlene is an expert in interpreting U.S. and international standards and regulations for clients. She additionally provides virtual executive leadership and strategic project support for several client companies advancing U.S. Class I, Class II and Class III medical devices and combination products. Her work primarily involves:
- Interface with U.S. and international regulatory agencies for product submissions
- Quality Management System development
- Quality Management System compliance support (e.g., FDA's Quality System Regulation (QSR), ISO 13485:2003, ISO 14971:2007, the European Medical Device Directive (MDD), and Health Canada’s Medical Devices Regulations)
- Product testing considerations and pre-clinical research
- Manufacturing, suppliers and distribution (e.g., validations, technology transfers, and supplier quality)
- FDA and international compliance activities (e.g., MDRs, Vigilance Reporting, and field actions)
- Clinical trial design and clinical trial management
PAST COMPANIES AND EXPERIENCE
Darlene started her medical device industry career in 1975 at Medtronic. She went on to work for Miles Laboratories, CooperVision Ophthalmic Products, and KeraVision, holding senior management positions for medical device companies since 1987. As KeraVision's Vice President of Regulatory Affairs, Clinical Research and Quality Systems, Darlene successfully led the company's efforts to obtain PMA approval for a new Class III ophthalmic implant and its associated surgical instruments, securing unanimous FDA Panel approval for the PMA product. She has been responsible for over 50 medical device clinical trials.
EDUCATION
Darlene received her BA degree in Biology from Augustana College in Sioux Falls, South Dakota and earned her MBA from the College of St. Thomas in Minneapolis, Minnesota. |
