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.
NewDirector, Regulatory Affairs Nova Pneuma, Inc.Director, Regulatory AffairsFremont, CAManage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.
NewHead of Quality Engineering & Regulatory Affairs Stirling QRHead of Quality Engineering & Regulatory AffairsMenlo Park, CAThe Head of Quality Engineering & Regulatory Affairs (Head of QERA) is a key executive reporting to the Chief Product Officer, responsible for building, leading and maintaining the company’s Quality and Regulatory Affairs functions and systems. They have multiple FDAcleared and CEmarked AI software products in routine clinical use across hundreds of hospitals and imaging centers worldwide, backed by a robust multimodality pipeline and strong investment in R&D.
NewSenior Director, Head of Regulatory Affairs Orca BioSenior Director, Head of Regulatory AffairsMenlo Park, CAEssential Duties & Key Responsibilities: Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the C-Suite, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements — with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves.
NewQuality Engineering & Regulatory Affairs Manager Stirling QRQuality Engineering & Regulatory Affairs ManagerMenlo Park, CAThey are transforming the healthcare ecosystem with responsible AI solutions that measurably improve radiology workflows and patient experience, with a vision that every person has access to timely diagnosis, highquality care and a longer, healthier life. This role is strategically critical for achieving commercialization goals, ensuring continuous improvement and that highquality AI/ML SaMD products reach emerging, regulated and clinical markets globally.
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, Regulatory Affairs - Advertising, Promotional and Labeling #4810 GRAILDirector, Regulatory Affairs - Advertising, Promotional and Labeling #4810Sunnyvale, CA$189,000–$271,000 / yearThe Director serves as a senior regulatory subject-matter expert and strategic business partner, who leads cross-functional teams in developing promotional materials to ensure compliance with global regulatory markets, while capturing potential regulatory risks. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
NewAssociate Director / Director, Regulatory Affairs GondolaBio Service Co, Inc.Associate Director / Director, Regulatory AffairsPalo Alto, CA$225,000–$275,000 / yearFor Associate Director, we expect 7+ years of pharmaceutical/biotechnology industry experience, at least 6 of which should be regulatory experience; for Director, we expect 10+ years of pharmaceutical/biotechnology industry experience, at least 8 of which should be regulatory experience. You thrive at the intersection of science, clinical development, and regulatory execution, bringing a pragmatic, solutions-oriented mindset to navigating complex regulatory pathways, including those relevant to rare diseases and accelerated development.
NewRegulatory Affairs Manager Gateway RecruitingRegulatory Affairs ManagerSan Jose, CAThe candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related areas.
NewRegulatory Affairs Manager DaikinRegulatory Affairs ManagerSanta Clara, CA$120,000–$145,000 / yearActing as a key liaison between engineering, government relations, Communications and Manufacturing, legal, and external regulatory bodies, the Regulatory Affairs Manager provides strategic guidance to support policy initiatives, market access, and long-term objectives. Collaborate cross-functionally with Regulatory Affairs, Engineering, Communications, Manufacturing, and Legal teams to ensure aligned advocacy positions.
NewDirector, Regulatory Affairs CMC - Cell Therapy & Novel Therapeutics RetroDirector, Regulatory Affairs CMC - Cell Therapy & Novel TherapeuticsRedwood City, CAAs one of the earliest members of the Regulatory Affairs team, you will work across Retro’s programs and play a leading role in building out the regulatory CMC capabilities and strategies to achieve our ambitious mission and tackle aging. You have high-collaboration and low-ego tendencies, with the ability to align cross-functional technical teams and external partners around a shared regulatory CMC plan and clear deliverables.
NewQuality & Regulatory Compliance Manager - Medical Devices BEPC INCQuality & Regulatory Compliance Manager - Medical DevicesMountain View, CA$85–$100 / hourSuccess in this role also requires hands-on medical device compliance experience, including MDSAP, Notified Body interactions, current FDA QMSR requirements, and the ability to build and strengthen a proactive Quality Culture in partnership with site and functional leadership. This role will support internal audit leadership, regulatory compliance activities, inspection readiness, and cross-functional collaboration across Local Operating Companies (LOCs) and Distribution Centers (DCs) within the EMEA region.
NewSenior Director, Regulatory CMC Senti BiosciencesSenior Director, Regulatory CMCSouth San Francisco, CA$245,000–$285,000 / yearProvide strategic CMC regulatory support, guidance and expertise, and act as the Regulatory Affairs primary point of contact to cross-functional teams including Pharmaceutical Development, Quality Assurance, Quality Control, contract organizations and consultants. Work across functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise.
NewDirector, CMC Regulatory Corvus PharmaceuticalDirector, CMC RegulatorySouth San Francisco, CA$230,000–$270,000 / yearReporting to the Vice President of Regulatory Affairs, the Director of Regulatory Affairs CMC will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturi ng, and Controls (CMC) regulatory strategies for clinical-stage small molecule programs. This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities.
NewCE-IVDR Regulatory Consultant AccuScan SciencesCE-IVDR Regulatory ConsultantMilpitas, CAJob Description AccuScan Sciences is seeking an experienced CE-IVDR Regulatory Consultant to lead and support European regulatory strategy for our oncology molecular diagnostics portfolio, including tumor-informed MRD assays and future kit-based products. The consultant will provide strategic and hands-on regulatory expertise to support CE-IVDR compliance, technical documentation development, performance evaluation strategy, Notified Body interactions, and commercialization of oncology molecular diagnostic products in Europe.
NewSupply Chain and Compliance Manager Carl Zeiss Meditec, Inc.Supply Chain and Compliance ManagerSunnyvale, CA$101,200–$126,500 / yearMinimum of 3 years of paid work experience, with at least one year of paid work experience in the past three years, related to the distribution or dispensing of dangerous drugs or dangerous devices in a licensed pharmacy, drug wholesaler, drug distributor, or drug manufacturer. The role also contributes to cross‐functional planning initiatives, driving process improvements, implementing scalable solutions to complex operational challenges, and supporting long‐term regional and global transformation projects as needed.
NewLocalization Manager (cur_1_130390@curatelyai.net) ASK ConsultingLocalization Manager (cur_1_130390@curatelyai.net)South San Francisco, CA$55–$56 / hourEnd-to-End Program Management : Lead the full localization lifecycle, from intake and scoping through Medical/Legal/Regulatory (MLR) review, for omnichannel marketing tactics (print, digital, social, email, web, SEO/SEM, campaigns) and Medical/Government Affairs content across 15+ product brands. Innovation Roadmap : Drive pilot programs and establish best practices for AI-powered localization capabilities (including Machine Translation and LLM integrations), collaborating with Product and Engineering teams to build scalable, repeatable workflows and new capabilities.
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.
Senior Product Manager - Remote IntradoSenior Product Manager - RemoteSan Jose, 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.