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Kimberly Lane, President and Principal Consultant at J Blane, LLC
Kimberly ("Kim") Lane provides regulatory services to medical companies ranging from sole proprietors to corporations with 100K+ employees. Ms. Lane holds a US Regulatory Affairs Certificate (RAC) from the Regulatory Affairs Professional Society (RAPS). In addition, Ms. Lane holds a Bachelor of Arts from Lehigh University.
Ms. Lane's Personal Statement:
What can I bring to your organization? If you are looking for a solid regulatory affairs professional with 16+ years’ experience who can chart a regulatory path for an early design concept or help bring an abandoned project back to life and achieve rapid worldwide regulatory approvals, look no further. Interfacing and negotiating with regulatory agencies should never be a barrier to any company’s success. A strong regulatory professional is unafraid of the unfamiliar, can succinctly propose a solid strategy to regulatory agencies, develop and maintain a trusting relationship with agencies by establishing an ongoing dialog of substance, collaborate with engineering, quality and marketing groups to help harmonize design and marketing goals, write compelling submissions and, of utmost importance, obtain the desired regulatory approvals. Experience highlights are:
- Authored over 175+ FDA 510(k), IDE and PMA submissions, supplements and reports with experience in generating up to 8 submissions per week.
- Specialty areas include: cardiovascular/vascular/neurovascular devices, dental devices, endovascular devices, drug/device combination products, human tissue products, IVDs, HCT/Ps, injection devices, medical device software, SaMD, Cybersecurity, AI-enabled devices, medical imaging devices, orthopedic devices and spinal devices.
- Wide range of negotiation skills -- from building relationshipes with FDA starting with early product development strategies for new technologies (breakthrough devices) to negotiating rapid approvals for line extension 510(k) and PMA devices.
- Extensive history in supporting new product development efforts and test protocol/report reviews, as well as early feasibility, feasibility and pivotal FDA investigational device exemption (IDE) clinical trials. Skills include and writing informed consent forms (ICF), study protocols, investigator brochures, instructions for use (IFU), adverse event reports and working rapidly with site coordinators to submit emergency use and compassionate use submissions.
- European Union regulatory expertise in interfacing with notified bodies and competent authorities, as well as researching and writing clinical evaluation reports (CERs), medicinal substance dossiers, design dossiers and technical files.
- International experience with the European Union, Australia, Canada, Brazil, Japan and China
- Background in consumer marketing and software systems, providing a unique understanding of how to quickly understand and align a regulatory strategy with marketing goals.
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