Regulatory Submissions Jobs in Sunnyvale, CA

The Sr. Clinical Research Engineer uses their in-depth clinical scientific and technical knowledge to collaborate with engineers physicians user experience researchers and other internal and external stakeholders to develop new product concepts being incubated in early exploration. The individual br...

Primary Function of PositionThe Sr. Regulatory Affairs serve as the primary regulatory representative on product and project teams supporting product lifecycle management activities. Responsibilities include developing regulatory plans reviewing design input/output documentation identification of ap...

Primary Function of PositionThis position will lead the drug product function within the CMC department. The Director of Drug Product will oversee all small molecule drug product development activities for Intuitives late-stage development programs ensuring timely regulatory submissions and the succ...

The Senior Epidemiologist Real-World Evidence Generation will design and execute data-drivenanalyses using claims databases and real-world evidence to demonstrate the clinical and economicvalue of emerging robotic platforms. This role focuses on rigorous statistical analysis of U.S.commercial and Me...

Primary Function of Position:The Post-market Clinical Follow-up Specialist provides leadership and expertise for the development of execution of PMCF for new and existing Intuitive products. This individual will lead cross-functional teams in the development of PMCF strategies track progress of PMCF...

About CeribellCeribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel point-of-care electroencephalography (EEG) platform specifically designed to address the unmet needs of patient...

About Us Catalyst Labs is a leading talent agency with a specialized vertical in Legal Regulatory Compliance and Corporate Governance. We operate deeply inside our clients hiring processes not as an external vendor but as an embedded extension of their executive and in-house legal teams. We collabor...

Primary Function of PositionThis position plays a critical role in delivering best-in-class financial reporting and supporting a high-performing finance organization within a complex multinational environment. It helps drive an efficient and accurate financial close process while contributing to lon...

Primary Function of PositionThis position reports to Manger/Sr. Manager Medical Sciences and requires a strong candidate with expertise in the analysis of medical literature data from clinical trials and pre-clinical studies and sound knowledge of applicable regulations and standards. The position w...

Primary Function of PositionWe are seeking an experienced Senior Program Manager to oversee and drive cross-functional development programs for small molecule therapeutics. This role will provide leadership and coordination across CMC non-clinical clinical and regulatory functions ensuring that prog...

Primary Function of PositionAs a Senior Manager of Clinical Affairs this role is responsible for contributing to clinical strategies and overseeing study execution for emerging technologies across various specialties.  Clinical trials in this portfolio may be both in the US and global and include fi...

Primary Function of PositionThe Post-Market Surveillance Specialist provides expertise and support for the development ofpost-market strategies plans and reports for new and existing Intuitive products. This teammember will work with cross-functional teams in the development of post-market strategie...

Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnologyAt Cepheid one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.Youll thrive in...

Primary Function of PositionThe Sr. Regulatory Affairs serve as the primary regulatory representative on product and project teams supporting product lifecycle management activities. Responsibilities include developing regulatory plans reviewing design input/output documentation identification of ap...

The Sr. Clinical Research Engineer uses their in-depth clinical scientific and technical knowledge to collaborate with engineers physicians user experience researchers and other internal and external stakeholders to develop new product concepts being incubated in early exploration. The individual br...

Primary Function of PositionThe Clinical Research Engineer within our Future Forward organization will lead the design and development of new product concepts prior to commercial launch by leveraging in-depth clinical scientific and technical expertise. This individual will collaborate closely with...

Primary Function of PositionThis role leads advanced product management engineering activities for complex medical devices supporting strategic business goals compliance and innovation.Essential Job DutiesLead requirements development and management for major product lines or platforms.Manage key te...

Primary Function of PositionThe Senior Clinical Research Engineer in our Future Forward organization will lead the design and development of new product concepts prior to commercial launch by leveraging in-depth clinical scientific and technical expertise. This individual will collaborate closely wi...

About CeribellCeribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel point-of-care electroencephalography (EEG) platform specifically designed to address the unmet needs of patient...

About CeribellCeribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel point-of-care electroencephalography (EEG) platform specifically designed to address the unmet needs of patient...