NewSr Regulatory Affairs Specialist, Global Market Kelly ServicesSr Regulatory Affairs Specialist, Global MarketSunnyvale, CARemote$47–$51 / hourKelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.
Regulatory Affairs Specialist IV JouléRegulatory Affairs Specialist IVMountain View, CA$60 / hourMinimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). • Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation and regulatory submissions.
NewDirector/Senior Director, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector/Senior Director, Regulatory Strategy (Pediatrics) - RemoteSan Francisco, CARemote$229,562–$344,342 / yearDirector level is expected to be between $229,562 and $344,342 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
NewRegulatory Specialist Sr ActalentRegulatory Specialist SrAlameda, CAJob Description Job Title: Regulatory Specialist Sr Job Description The Regulatory Specialist Sr plays a key role in ensuring timely approval of new medical devices and maintaining continued approval of marketed products. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
NewPrincipal Supplier Quality Engineer THINK Surgical, Inc.Principal Supplier Quality EngineerFremont, CAPartner cross-functionally with Engineering, Operations, Manufacturing, Supply Chain, Regulatory Affairs, and externals suppliers to ensure supplier quality requirements are effectively defined, implemented, maintained, and in compliance with FDA Quality Management System Regulation (21 CFR Part 820/QMSR), ISO 13485, ISO 14971, and other applicable regulatory requirements. The Principal Supplier Quality Engineer leads complex supplier quality initiatives, drives supplier quality strategy, mentors quality professionals, and provides leadership in resolving high-risk supplier quality issues.
NewSenior Product Manager - Remote IntradoSenior Product Manager - RemoteSan Francisco, CARemote$120,000–$150,000 / yearWorking within Intrado’s product operating model, you will partner closely with Sales, Customer Success, Engineering, Network Operations, Product Operations, Regulatory Affairs, and telecommunications service providers to define and deliver solutions that meet evolving customer, industry, and regulatory requirements. The ideal candidate brings experience in telecommunications, emergency communications, or network-based services and has a strong understanding of Wireline, VoIP, NG911, location information services, and the public safety ecosystem.
NewHigh Pressure Boiler Plant Operator/Stationery Engineer 22nd Century Technologies Inc. (TSCTI)High Pressure Boiler Plant Operator/Stationery EngineerPalo Alto, CAWe are a trusted partner to Federal, State, Local, Education (SLED), Healthcare, and Commercial organizations, delivering innovative technology and talent solutions that enable our clients to achieve their strategic objectives.\r\n\r\nAs one of the nation's leading Healthcare Workforce Solutions providers, TSCTI supports federal healthcare systems, Veterans Affairs (VA) Medical Centers, state and local healthcare agencies, hospitals, clinics, laboratories, long-term care facilities, and commercial healthcare organizations. Today, we proudly support 14 of the 15 Federal Executive Departments, 37 Federal agencies, 50 State governments, 115+ Local agencies, 37 School Districts, numerous healthcare organizations, and 80+ Fortune 500 and commercial clients.\r\n\r\nTSCTI has earned numerous industry recognitions, including being named among Forbes America's Best Large Employers, Forbes Best Employers for Veterans, Forbes Best Employers for Tech Workers, Newsweek's America's Greatest Workplaces for Diversity, and a 13-time Inc. 5000 honoree.
Director, Corporate Communications - Remote CircleDirector, Corporate Communications - RemoteSan Francisco, CARemote$200,000–$257,500 / yearDemonstrated track record at a publicly traded or pre-IPO company, with deep expertise in financial communications and direct ownership of the earnings process — including coordinating materials, managing media during quiet periods, and partnering with investor relations and legal through reporting windows. Circle’s platform includes the world’s largest regulated stablecoin network anchored by USDC, Circle Payments Network for global money movement, and Arc, an enterprise-grade blockchain designed to become the Economic OS for the internet.
NewSenior Director, Clinical Education and Events Dentsply SironaSenior Director, Clinical Education and EventsSan Francisco, CAThis leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.
NewTriage Analyst - Zero Balance AspirionTriage Analyst - Zero BalanceAlameda, CARemote$25–$32 / hourReview documentation from payer portals, client systems, provider notes, explanation of benefits (EOBs), remittance advice, and other sources to understand account history and claim status, communicate with insurance carriers and internal stakeholders as needed to clarify claim status, and support the development of comprehensive appeal submissions. Support Compliance Program by adhering to policies and procedures pertaining to HIPAA, GLBA, FCRA, and other laws applicable to business practices; this includes becoming familiar with Code of Ethics, attending training as required, notifying management when there is a compliance concern or incident, HIPAA-compliant handling of patient information, and demonstrable awareness of confidentiality obligations.
Regulatory Affairs Associate Jess BusheyRegulatory Affairs AssociateMountain View, California$75,000–$95,000Coordinate and maintain regulatory documentation, including preparation for local and regional registrations, license renewals, and product submissions. This role is pivotal in ensuring compliance with various global regulations, including FDA 21 CFR 820, EN ISO 13485, and the European Medical Regulation (MDR).
Regulatory Affairs Associate Heluna HealthRegulatory Affairs AssociateSan Francisco, CaliforniaUnder the direction of Susan Buchbinder, MD, Bridge HIV has been conducting HIV and STI preventive vaccine studies, HIV pre-exposure prophylaxis (PrEP) studies (including oral and injectable medications), and other studies of biomedical HIV prevention strategies since the early days of the epidemic. The Bridge HIV Investigators are global leaders in HIV vaccine and prevention science, epidemiology of HIV infection, HIV medication adherence, combination HIV prevention strategies, and HIV research training methods.
Associate Director, Regulatory Affairs Advertising and Promotion Mirum PharmaceuticalsAssociate Director, Regulatory Affairs Advertising and PromotionFoster City, California$205,000–$225,000 / yearManage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP). Bachelor’s or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products.
Director, Regulatory Affairs (Strategy, I&I) Nurix Therapeutics, Inc.Director, Regulatory Affairs (Strategy, I&I)Brisbane, CAThis role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications.
Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors) Nurix Therapeutics, Inc.Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)Brisbane, CA$232,000–$274,000 / yearThis role will be responsible for developing and executing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy, guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of registration and life cycle management activities. Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications.
Associate Director, Regulatory Affairs Advertising And Promotion Mirum Pharmaceuticals IncAssociate Director, Regulatory Affairs Advertising And PromotionFoster City, CA$205,000–$225,000 / yearEducation /Experience: Bachelor's or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products. Manage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
Manager, Regulatory Affairs iRhythmManager, Regulatory AffairsSan Francisco, CaliforniaRemote$127,000–$165,000 / yearLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
Sr Director, Regulatory Affairs RezoluteSr Director, Regulatory AffairsRedwood City, CaliforniaAs Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders. Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs will join the regulatory team providing strategic and operational leadership supporting late-stage clinical development through regulatory submission, approval, and product launch.
Associate Director, Global Regulatory Affairs Project Management Revolution Medicines, Inc.Associate Director, Global Regulatory Affairs Project ManagementRedwood City, CA$186,000–$233,000 / yearDrive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead's strategic vision. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development.
Associate Director, Regulatory Affairs Project Planning & Coordination ACADIA Pharmaceuticals Inc.Associate Director, Regulatory Affairs Project Planning & CoordinationSouth San Francisco, CA$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.