Cindy K.

Background

About Cindy K.

Eighteen years’ experience directing global clinical programs for medical products, combination technologies, devices, software and equipment. Directed two successful Class PMA programs resulting in accelerated approvals. Extensive clinical and product development background including clinical practice (ICU/CCU RN), strategic focus, clinical studies (proof of concept, pivotal, IDE/PMA/HDE/ISR, CE Mark, human factors) and post-market programs. Effective leadership for global programs conducted according to regulated standards (FDA/ISO/ICH/AdvaMed); completed regulatory audits (US/OUS) with no observations. Developed and managed collaborative cross-functional teams to complete programs and product approvals in an expedited, cost-effective manner that increased value for internal stakeholders, KOLs, medical professionals, regulatory agencies, payers and patients. Hands-on, goal oriented leader with an in-depth understanding of the clinical, medical, regulatory and commercial aspects of the entire product life cycle. Specialties: Extensive global experience including: pre-clinical, first-in-man, pivotal, post-market, physician sponsored studies and reimbursement programs in the US, Canada, Europe, South America, Asia, Australia and New Zealand.