Victoria Rendon

About Victoria Rendon

I have more than 20 years experience within the Medical Device (US Class II and Class industry. I bring strong project management skills, the ability to navigate complex matrix organizations, an understanding of the medical device development / regulatory / clinical trial milestones, and the drive to facilitate common ground between physician /patient needs and medical technology. I have 7 years experience as a Senior Clinical Program Manager within the Medical Affairs and Education team. High-level responsibilities include strategic evidence planning (including program management of data analysis to support the evidence dissemination strategy) and dissemination tactics for scientific podium (CME and Non-CME)). I also manage the peer-reviewed publication strategy, KOL alignment on data and messaging, the manuscript development process and metrics demonstrating the success of the manuscript development process. I currently manage one (1) direct report and two (2) contingent employees.In addition to the clinical / medical affairs experience, I have 15 years experience leading and managing submissions for US Class II (510 (k)) and Class (IDE/PMA) products as well as technical files for EU Class IIa and IIb and design dossiers for class products. Submissions included new product development PMA & 510k, Original IDE, manufacturing/product/labeling changes, deficiency responses to various regulatory agencies, annual updates as well as review of promotion/advertising materials. I additionally managed the Regulatory Operations team, implementing processes to standardize and streamline the submission publication process. In my tenure as a regulatory professional, I have managed a group of up to 10 individuals at at time.Specialties: Medical Device, Medical Affairs, Regulatory Affairs, Project Management, Evidence Planning, Publication Planning, KOL, Regulatory Submission Strategy, Collaborative, Ability to lead a team to execute and achieve business goals.Victoria Rendon

Experience

1. Director, Scientific Communications

   Shockwave Medical

   Jul 2022 — Present · US

Education

• Drury University

  Bachelor of Arts, Biology, Chemistry, Environmental Studies

  1993 — 1997

• Sonoma State University

  MBA, Business

  2010 — 2012

• Drury University

  Bachelor of Arts - BA, Biology/Biological Sciences, General

  1993 — 1997

• Drury University

  Bachelor of Arts - BA, Biology, General

Skills

• Medical Device
• Pma
• Regulatory Affairs