Valerie joined Experien Group (now Veranex) in 2011 with over 20 years of regulatory affairs experience at both small and large medical device companies. Her professional background includes regulatory affairs, regulatory compliance, clinical research, and product development. Valerie has obtained numerous regulatory clearances and approvals from the FDA and has actively participated in multiple FDA and state of California FDB inspections. She has secured the CE mark and international registrations for a myriad products, and participated in numerous successful notified body audits. Additionally, Valerie has written protocols for clinical trials in support of PMA submissions and has been involved in U.S. and international clinical studies. In her regulatory capacity, Valerie has worked closely with company marketing and business development teams to ensure that product labeling and marketing materials are compliant to relevant standards.
At Veranex, Valerie manages clients’ regulatory requirements for product development, manufacturing, clinical trials, submissions, commercialization activities, and postmarket compliance. Valerie is responsible for formal and informal communications with the FDA as well as international regulatory agencies. Valerie’s primary functions include:
- U.S. and international regulatory/clinical strategies
- Regulatory representative on client companies’ design teams for medical devices and combination products
- Clinical trial management
- Pre-IDE packages and client interface for pre-IDE meetings
- U.S. FDA regulatory submissions (e.g., IDEs, 510(k)s, PMAs, HUDs/HDEs and de novos)
- Designing dossiers and technical files for CE marking as well as international registrations
- Advertising, labeling, and promotion compliance
- Interfacing with FDA inspectors, notified body auditors, and state of California FDB inspectors
Past companies and experience
Valerie has experience in all aspects of the medical device industry from product development through commercialization. She has been personally responsible for numerous regulatory clearances and approvals (U.S. and international) and is an expert in regulatory compliance activities, including QSR and ISO requirements, product complaint evaluation, MDR and vigilance reporting, and corrective action resolution.
Valerie’s regulatory career began at CooperVision. She then joined another ophthalmic company, KeraVision, as a regulatory affairs manager under Darlene Crockett-Billig, supporting the company’s successful PMA approval efforts. Then Valerie gained cardiovascular experience at Guidant before moving on to a senior director position at ArthroCare where she managed all regulatory activity for their arthroscopy, spine, and ENT medical devices.
Valerie received her B.A. in chemistry from San Jose State University in San Jose, California.