Full-Time

Director – Medical Device Safety

Confirmed live in the last 24 hours

ReCor Medical

ReCor Medical

201-500 employees

Ultrasound renal denervation technology provider

Hardware

Mid, Senior

Palo Alto, CA, USA

Required Skills
Communications
Requirements
  • Minimum of a MD, DO, MBBS, PhD
  • Minimum of 3-5 years medical safety and vigilance with knowledge of US, European, and other global regulations
  • Experience with post market safety surveillance is a plus
  • Experience in medical devices or combination products is strongly preferred
  • Strong collaboration skills with cross functional teams
  • Strong critical thinking skills
  • Ability to work independently
  • Strong communication and presentation skills
  • Active Medical license preferred
  • Located within commutable distance to Palo Alto with the ability to be onsite 5 days per week (minimum of 3 days per week). COVID-19 vaccination requirements
Responsibilities
  • Develop global vigilance/safety reporting processes and a team to support those goals
  • Responsible for oversight of Clinical Safety Team and Imaging Team
  • Lead and support clinical safety and imaging team managers
  • Responsible for the monitoring, signal detection, analysis, interpretation, and documentation of medical safety information including safety events, literature, and other sources
  • Ensure timely and appropriate global reporting of clinical and commercial products
  • Manage governance goals (DSMB, Imaging Corelab, independent adjudicators, and others)
  • Responsible for strategic safety and imaging communication to cross-functional ReCor teams
  • Participates in strategic decision making for maintaining and developing global safety database
  • Support writing, review, and submission of ad hoc reports, narratives, IFU, annual/quarterly reports, CER, PMCF, PSUR
  • Manage Health Hazard Assessments
  • Support Medical Affairs safety guidance to internal and external teams
  • Perform medical risk benefit assessments and provide support to Quality Affairs and R&D
  • Align ReCor Medical Affairs with global/Otsuka Medical Devices
  • Promote a growth environment

The Paradise™ Ultrasound Renal Denervation (uRDN) System by ReCor Medical utilizes ultrasound energy delivered by a balloon catheter to target overactive renal nerves, potentially reducing blood pressure and medication dependency through a minimally-invasive procedure.

Company Stage

Series D

Total Funding

$37.9M

Headquarters

Palo Alto, California

Founded

2009

Growth & Insights
Headcount

6 month growth

15%

1 year growth

56%

2 year growth

103%