ReCor Medical
Pioneers of Ultrasound Renal Denervation (uRDN) to treat hypertension
hypertension • medical device • Intervention cardiology
51 - 200
Director, Medical Device Safety
July 24
🏢 In-office - Bay Area
ReCor Medical
Pioneers of Ultrasound Renal Denervation (uRDN) to treat hypertension
hypertension • medical device • Intervention cardiology
51 - 200
Description
• 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
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).
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