Director, Medical Device Safety

2 weeks ago

Palo Alto CA United States Recor Medical Inc. Full time
At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.The Director, Medical Device Safety will be responsible for leading global safety and imaging for clinical and commercial use of Recor Medical products. Responsibilities include managing a growing team of physicians and scientists who support Safety and Imaging teams.The position requires experience leading and developing vigilance/safety reporting processes globally and developing/managing teams to support those goals. This position requires device and medical safety background within clinical trials and commercially. The position will work cross-functionally with the global organization. Managers in Clinical Safety and Clinical Imaging will report into this position. The position reports to the Vice President, Medical Affairs.Responsibilities including but not limited to:
  • 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 environmentRequirements:
    • 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).
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