Sr. Regulatory Affairs Specialist JouléSr. Regulatory Affairs SpecialistMountain View, CA$55–$60 / hourSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Provide regulatory guidance to product teams, develop strategies for the U.S. and Canadian markets, and influence global regulatory strategies.
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.
Project Manager (Lifesciences/Biotech- Medical affairs) Tanisha SystemsProject Manager (Lifesciences/Biotech- Medical affairs)Foster City, CAFull timeThe role will serve as the primary liaison between stakeholders, Medical Affairs, business teams, IT teams, vendors, and delivery partners to ensure successful planning and execution of projects and operational initiatives. Proven track record managing enterprise application and business transformation projects; Ability to manage scope, schedules, resources, budgets, risks, and dependencies.
Senior 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.
NewRelationship Manager I City National BankRelationship Manager IPleasanton, CARemote$65,296–$104,304 / yearKey measures of success include acquisition of new personal and new small business clients, deposit and fee income growth from both new and existing portfolios, loan and line volume that includes but is not limited to CRA-eligible fundings, excellent risk management mitigation, as well as the qualitative sales, networking, and community presence activities that generate the aforementioned volumes and represent City National with polished professionalism. Capture holistic view of client’s needs – draw insights from data to provide sound financial advice (strategies, products / solutions); conduct discovery activities with existing clients to grow current book e.g., deposits, investments, credit.
Director, Corporate Communications - Remote CircleDirector, Corporate Communications - RemoteSan Jose, 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.
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.
Senior 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.
Manager, Regulatory Affairs, Regulatory PMO Google LLCManager, Regulatory Affairs, Regulatory PMOMountain View, CAOversee and lead a team partnering with legal counsel, product teams, and other cross-functional stakeholders to drive strategy, share information, and implement program management principles across our largest and most complex matters (including litigation, internal investigations, and regulatory requests). Lead the development of project, program, and portfolio management methodologies, identifying opportunities for cross-organizational process improvement initiatives and knowledge management projects.
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.
Senior Director, Regulatory Affairs Policy, Regulatory Intelligence & Compliance Exelixis IncSenior Director, Regulatory Affairs Policy, Regulatory Intelligence & ComplianceAlameda, CAThe position oversees the surveillance, triage, interpretation, and dissemination of global regulatory intelligence across Research & Development (R&D), Quality (QA), Information Technology (IT) and Pharmaceutical Supply Chain (PSC), partnering with cross-functional subject matter experts to ensure impact assessments are conducted and documented. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BA/BA degree in related discipline and 15 years of related experience; or, MA/MA degree in related discipline and 13 years of related experience; or, PhD in related discipline and 12 years of related experience; or, Equivalent combination of education and experience.
Regulatory Affairs Associate (Principal) - Medical Devices Apple IncRegulatory Affairs Associate (Principal) - Medical DevicesCupertino, CAThis role will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans in the US and globally. You will represent the RA/QA team on a diverse array of regulatory initiative teams and new product development, with the goal of obtaining approvals for new technologies.
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.
Associate Director, Regulatory Affairs (Onsite in S.SF – 3X/wk) Zai Lab LtdAssociate Director, Regulatory Affairs (Onsite in S.SF – 3X/wk)South San Francisco, CA$198,000–$257,000 / yearProfessional Conduct: Execute responsibilities with professionalism, integrity, and attention to detail while working effectively across time zones and supporting a collaborative team environment.\n \nQualifications\n \nREQUIRED:\n\n Bachelor's degree in life sciences with 10 years' experience in the biopharmaceutical industry of which 8 years are in regulatory affairs; or equivalent combination of education, training, and experience\n \nPREFERRED:\n\n Advanced degree in life sciences, pharmacy, or a related field (MS, PhD, PharmD, or equivalent).\n Regulatory Guidance: Provide day\u2011to\u2011day clinical regulatory guidance to cross\u2011functional teams by interpreting regulations, policies, and guidance documents and applying them to program activities, including providing regulatory input into clinical development documents such as protocols, Investigator's Brochures, and study reports to ensure alignment with regulatory expectations.\n
Vice President, Regulatory And Head Of Regulatory Affairs Sagimet Biosciences IncVice President, Regulatory And Head Of Regulatory AffairsSan Mateo, CA$340,000–$370,000 / yearThis role will serve as the primary liaison with global regulatory authorities and involve close collaboration with Sagimet's cross-functional teams and external partners, to ensure the successful advancement of our clinical programs. Position Summary: The VP of Regulatory and Head of Regulatory Affairs will shape and execute regulatory strategies and lead and manage submissions to support clinical development and regulatory compliance for Sagimet.
Vice President, Regulatory and Head of Regulatory Affairs Sagimet Biosciences IncVice President, Regulatory and Head of Regulatory AffairsSan Mateo, CA$340,000–$370,000 / yearThis role will serve as the primary liaison with global regulatory authorities and involve close collaboration with Sagimets cross-functional teams and external partners, to ensure the successful advancement of our clinical programs. Oversee the companys external regulatory advisors, consultants and vendors to ensure that relevant regulatory advice is provided with respect to the companys development programs.
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 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.
Manager, Regulatory Affairs iRhythm TechnologiesManager, Regulatory AffairsSan Francisco, CARemote$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.