14 Results for

Regulatory Affairs Specialist Jobs in Santa Clara, CA

Jobs

Palo Alto, CA30+ days ago

$145,000–$167,000 Per Year

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop®system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations:Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.

Burlingame, CA30+ days ago

Review significant regulatory issues with manager, as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level.

SF, CA30+ days ago

POSITION SUMMARY:The Senior Regulatory Affairs & Compliance Specialist is responsible for ensuring compliance with regulatory, licensing, and contractual requirements set forth by the Centers for Medicare and Medicaid Services (CMS), the California Department of Health Care Services (DHCS), and other regulatory agencies. Seniors, their family members, and caregivers face many issues, including transportation to appointments, management of medications, coordination of medical care from different specialists, lack of social interaction, and ability to stay alone at home.

Mountain View, CA30+ days ago

$75,000–$95,000 Per Year

Perform and document Complaint Handling, assessment, and reporting Receive and investigate product- and service-related communications / complaints, with communication received from various sources, including communications from field service management platforms (ServiceMax), customer relationship management platforms (SalesForce), enterprise resource planning platforms (Business Central), internal service records, and other direct and indirect customer/user communications. Regulatory Affairs (Associate / Specialist / Senior Specialist) Post Market Surveillance personnel are responsible for: (1) analyzing Post Market Surveillance (PMS) data to prepare Post Market Surveillance reports and documentation, and to update related risk and other documentation accordingly.

Mountain View, California30+ days ago

$80,000–$80,000

Ultimate Staffing Services is actively seeking a dedicated and detail-oriented Regulatory Affairs Associate to join a reputable medical device manufacturer. Coordinate, prepare, compile, and maintain regulatory documentation for local and regional registration, license renewal, and product submissions.

South San Francisco, CA9 days ago

Remote

$170,000–$210,000 Per Year

Reporting to the Senior Director, Regulatory Affairs, this position will serve as a core regulatory representative on cross‑functional program teams, supporting interactions with global health authorities and ensuring regulatory strategies and submissions are aligned with evolving regulatory expectations for cell and gene therapies. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

Palo Alto, CA25 days ago

The Associate Director ensures will be working on biostatistics deliverables, including study design, data analysis, data mining, epidemiology-related analyses, use of clinical trial data to inform reimbursement strategy and HTA, real world evidence, quality of life data, and interpretation, reporting, and publication of results. The Associate Director, Medical Affairs Statistical Sciences Biometrics provides technical and operational support for the design, implementation and interpretation of post approval clinical trials, programs, and disease registries.

Santa Clara, CA30+ days ago

Act as an extension of the clinical study team by identifying investigators, nominating sites, providing training, encouraging enrollment, ensuring quality data acquisition, and performing study closure activities. The Field Clinical Specialist serves as a key bridge between the cath lab and the internal product team, supporting clinical readiness across physicians, cath lab nurses, and investigational sites.

Santa Clara, CA30+ days ago

$144,010–$301,610 Per Year

Job Type: Experienced HireShift: Shift 1 (United States of America)Primary Location: US, California, Santa ClaraAdditional Locations: US, Arizona, Phoenix, US, California, Folsom, US, Oregon, Hillsboro, US, Washington, D.C.Business group: Intel’s Corporate Affairs, Policy, Integrity, Trade, and Legal (CAPITL) group offers unique opportunities to work in a variety of areas, including counsel to Intel businesses; technology and intellectual property licensing; patent prosecution; trademarks and brands; litigation, mergers, acquisitions and investing; public policy, legislative and regulatory lobbying; global trade, export, import, and customs; and corporate compliance. As part of the Americas ECSC team, this position involves close collaboration with ECSC colleagues in Asia and Europe, while engaging regularly with business leaders, legal counsel, industry partners, and government officials to ensure seamless compliance operations.

South San Francisco, CA30+ days ago

$209,700–$389,500 Per Year

Serving as lead legal counsel for global development programs involving innovative scientific initiatives with external collaborators including pharmaceutical manufacturers, digital or device developers, academic institutions, research collaborative groups, and government entities; + Proactively identifying and addressing enterprise-wide legal issues, based on an excellent understanding of business strategy and goals, fostering trusted relationships with client groups, advising leaders in the R&D and Medical Affairs organizations, serving as a standing or ad hoc member of business or leadership team(s); and. + Consulting and collaborating with internal and external stakeholders and subject matter experts to support the above activities, our internal legal colleagues (IP, transactional, privacy, and product attorneys) as well as VP-level business leadership, regulatory experts, ethics experts, and legal policy committee members.

New!

Menlo Park, CA3 days ago

$100,000–$140,000

The Senior Quality Specialist is responsible for ensuring the effective execution of core Quality Management System (QMS) processes, including Document Control, Records Management, and Training, required for quality and manufacturing regulatory compliance. Manage Document Change Orders (DCOs), including reviewing and processing DCOs, performing cross references, logging approvals; primary point of contact for change orders.

San Francisco, CA30+ days ago

$180,000–$195,000 Per Year

Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. Headquartered in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

Burlingame, CA30+ days ago

$92,114–$156,880 Per Year

This may be accomplished through active calling efforts and referrals from existing customers and line colleagues from Personal & Business Banking and other divisions, and by providing the CNB exemplary level of service, identifying and promoting solutions to customer needs, and maintaining an active calling program. Preferred to be in good standing under "The Secure and Fair Enforcement for Mortgage Licensing Act of 2008" (Safe Act) and be registered/licensed with the "Nationwide Mortgage Licensing System and Registry" (NMLS); or must be able to be registered under the Safe Act.

San Francisco, CA30+ days ago

$92,114–$156,880 Per Year

This may be accomplished through active calling efforts and referrals from existing customers, providing the CNB exemplary level of service, identifying and promoting solutions to customer needs, and maintaining an active calling program. * Relationships in portfolio may contain numerous accounts requiring extensive operational expertise to manage workflow to match client needs, risk control and maximize cross selling potential.

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Regulatory Affairs Specialist Jobs in Santa Clara, CA

Jobs

Senior Regulatory Affairs SpecialistHyperfine

Medical Devices, Regulatory Affairs SpecialistMeta

Snr Regulatory Affairs & Compliance Specialist PACEOn Lok

Regulatory Affairs - Post Market SurveillanceIridex Corporation

Regulatory Affairs AssociateJess Bushey

Associate Director, Regulatory AffairsAllogene Therapeutics

Associate Director, Medical Affairs Statistical Sciences, Biometrics - ID: 1799Ascendis Pharma

Field Clinical Specialist - VahatiCorT45 Labs

Senior Export Compliance SpecialistIntel

Senior Counsel Specialist, Assistant General Counsel- R&D Law GroupGenentech

Senior Quality SpecialistE2HELO

Director, Commercial TrainingElement Science

Relationship Manager Business Banking SrCity National Bank

Relationship Manager TechnologyCity National Bank

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