Recor Medical Inc.
Director, Medical Device Safety
Recor Medical Inc., Palo Alto, California, United States, 94306
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 goalsResponsible for oversight of Clinical Safety Team and Imaging TeamLead and support clinical safety and imaging team managersResponsible for the monitoring, signal detection, analysis, interpretation, and documentation of medical safety information including safety events, literature, and other sourcesEnsure timely and appropriate global reporting of clinical and commercial productsManage governance goals (DSMB, Imaging Corelab, independent adjudicators, and others)Responsible for strategic safety and imaging communication to cross-functional ReCor teamsParticipates in strategic decision making for maintaining and developing global safety databaseSupport writing, review, and submission of ad hoc reports, narratives, IFU, annual/quarterly reports, CER, PMCF, PSURManage Health Hazard AssessmentsSupport Medical Affairs safety guidance to internal and external teamsPerform medical risk benefit assessments and provide support to Quality Affairs and R&DAlign ReCor Medical Affairs with global/Otsuka Medical DevicesPromote a growth environmentRequirements:
Minimum of a MD, DO, MBBS, PhDMinimum of 3-5 years medical safety and vigilance with knowledge of US, European, and other global regulationsExperience with post market safety surveillance is a plusExperience in medical devices or combination products is strongly preferredStrong collaboration skills with cross functional teamsStrong critical thinking skillsAbility to work independentlyStrong communication and presentation skillsActive Medical license preferredLocated 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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Develop global vigilance/safety reporting processes and a team to support those goalsResponsible for oversight of Clinical Safety Team and Imaging TeamLead and support clinical safety and imaging team managersResponsible for the monitoring, signal detection, analysis, interpretation, and documentation of medical safety information including safety events, literature, and other sourcesEnsure timely and appropriate global reporting of clinical and commercial productsManage governance goals (DSMB, Imaging Corelab, independent adjudicators, and others)Responsible for strategic safety and imaging communication to cross-functional ReCor teamsParticipates in strategic decision making for maintaining and developing global safety databaseSupport writing, review, and submission of ad hoc reports, narratives, IFU, annual/quarterly reports, CER, PMCF, PSURManage Health Hazard AssessmentsSupport Medical Affairs safety guidance to internal and external teamsPerform medical risk benefit assessments and provide support to Quality Affairs and R&DAlign ReCor Medical Affairs with global/Otsuka Medical DevicesPromote a growth environmentRequirements:
Minimum of a MD, DO, MBBS, PhDMinimum of 3-5 years medical safety and vigilance with knowledge of US, European, and other global regulationsExperience with post market safety surveillance is a plusExperience in medical devices or combination products is strongly preferredStrong collaboration skills with cross functional teamsStrong critical thinking skillsAbility to work independentlyStrong communication and presentation skillsActive Medical license preferredLocated 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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