NewDirector Regulatory Affairs - CMC Clinical Dynamix, Inc.Director Regulatory Affairs - CMCSan Diego, CAResponsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects. Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies.
NewManager, Materials Management Buyer/Planner Artiva BiotherapeuticsManager, Materials Management Buyer/PlannerSan Diego, CA$130,000–$145,000 / yearThis role requires close collaboration with internal and external partners—including Manufacturing, Process Development, Analytical Development, QA/QC and raw material suppliers—as well as internal stakeholders across, Finance, procurement Manufacturing, and Regulatory Affairs, to maintain supply continuity, regulatory compliance, and operational excellence. This role will own the full Raw Material lifecycle—from raw material planning and ordering through inventory control—ensuring uninterrupted, compliant, and cost-effective material flow to support clinical Manufacturing, Analytical Development, and Process Development.
NewProject Manager (Federal Projects) Fedvet ConstructionProject Manager (Federal Projects)El Cajon, CAJob Description FedVet Construction is seeking an experienced Project Manager with proven success delivering federal construction projects for agencies such as the Naval Facilities Engineering Systems Command (NAVFAC) , U.S. Army Corps of Engineers (USACE), National Park Service (NPS), Bureau of Reclamation (BOR), and the Department of Veterans Affairs (VA). The Project Manager will lead a project team that includes the Superintendent, Quality Control Manager (QCM), Site Safety and Health Officer (SSHO), and Project Coordinators, while serving as the primary point of contact with federal clients.
NewMedical Device Engineer 3 ActalentMedical Device Engineer 3San Diego, CA$56–$68 / hourJob Description Job Title: Medical Device Engineer 3 Job Description The Senior Medical Device Engineer will develop and optimize polymer-based membrane coatings for advanced biosensor products, combining hands-on laboratory work with detailed technical documentation to support product design, process development, qualification, validation, and commercialization in a regulated medical device environment. 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.
Senior Manager, QA & Regulatory Affairs Agena Bioscience Inc.Senior Manager, QA & Regulatory AffairsSan Diego, CA$154,500–$193,250 / yearPart timeThe Senior Manager leads cross-functional quality and regulatory initiatives, manages audit readiness and regulatory submissions, and develops a high-performing team that supports business objectives and global compliance requirements. The Senior Manager, Quality & Regulatory Affairs is responsible for overseeing the development, implementation, and continuous improvement of the organization’s Quality Management System (QMS) and Regulatory Affairs programs.
Associate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) CorDxAssociate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)San Diego, CAWith over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle.
Associate Director, Regulatory Affairs Project Planning & Coordination ACADIA Pharmaceuticals Inc.Associate Director, Regulatory Affairs Project Planning & CoordinationSan Diego, 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.
Sr Manager/Assoc Director, CMC Regulatory Affairs ErascaSr Manager/Assoc Director, CMC Regulatory AffairsSan Diego, CAAssess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies. Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements.
NewRegulatory Affairs Manager - IVD CorDxRegulatory Affairs Manager - IVDSan Diego, CAThe Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic products, including FDA 510(k), CLIA categorization/waiver activities, and other applicable regulatory pathways. CorDx Inc. is seeking an experienced Regulatory Affairs Manager to support the development, registration, and lifecycle management of in vitro diagnostic (IVD) medical devices in the United States.
Sr Regulatory Affairs Specialist DexComSr Regulatory Affairs SpecialistSan Diego, California$91,400–$152,300 / yearRegulatory Affairs Specialist will be responsible for supporting product classifications, change assessments, registration and approval for software products, including mobile applications, AI/ML enabled data products, cloud-based solutions and cybersecurity initiatives. You are the RA representative on core functional teams for global software regulatory classification, change management, and regulatory submissions including: US 510(k), pre-submissions, LTF, MDDS change assessment.
Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) CorDxRegulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)San Diego, CAWith over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.
Senior Regulatory Affairs Manager (Onsite) CorDxSenior Regulatory Affairs Manager (Onsite)San Diego, CAWith over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions.
Director, Regulatory Affairs (Labeling) Arrowhead PharmaceuticalsDirector, Regulatory Affairs (Labeling)San Diego, CA$210,000–$230,000 / yearManage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Associate Director / Director, Regulatory Affairs - CMC Iambic TherapeuticsAssociate Director / Director, Regulatory Affairs - CMCSan Diego, CaliforniaThis individual will partner closely with Technical Operations, Process Chemistry, Analytical Development, Formulation, Manufacturing, Quality, Clinical, Nonclinical, Regulatory Operations, and external partners, and will support interactions with the US FDA and other global health authorities as appropriate. Monitor global CMC regulations, identify CMC regulatory risks, gaps, and dependencies; develop mitigation strategies and communicate collected intelligence, precedence and potential impacts on program timelines, submission plans, and product development decisions.
Head of Global Regulatory Affairs (U.S. Remote) Adagene IncorporatedHead of Global Regulatory Affairs (U.S. Remote)San Diego, CARemoteMust have extensive knowledge of regulatory requirements, including ICH GCP, GMP, GLP, and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business. As a Head of Global Regulatory Affairs this person will perform a critical role in strategies, documentations, submissions, and company interactions to regulatory authorities such as FDA, CFDA, and other regulatory agencies.
Regulatory Affairs Specialist DexComRegulatory Affairs SpecialistSan Diego, CaliforniaWith our various backgrounds and talents we help to navigate and align the ideas and output of most facets of the company to successfully get our home-use products to our end users. You bring knowledge of US and international regulatory requirements including design control, medical device submission requirements, labeling and promotion regulations, and medical device quality systems.
Senior Director, Global Regulatory Affairs Janux TherapeuticsSenior Director, Global Regulatory AffairsSan Diego, CaliforniaThis role requires a hands-on regulatory leader with deep experience in early clinical development (Phase 1/2), coordinating multiple parallel regulatory initiatives, strong health authority interaction experience, the ability to exercise judgment with decisions that have long-term impact on regulatory function success, and guide teams through ambiguity and evolving data. This individual will lead global regulatory strategy for one or more programs while influencing and partnering closely with cross-functional stakeholders to shape development plans and ensuring alignment across functions in a dynamic, fast-paced environment.
Senior Director, Global Regulatory Affairs Janux Therapeutics Inc.Senior Director, Global Regulatory AffairsSan Diego, CA$240,000–$275,000 / yearThis role requires a hands-on regulatory leader with deep experience in early clinical development (Phase 1/2), coordinating multiple parallel regulatory initiatives, strong health authority interaction experience, the ability to exercise judgment with decisions that have long-term impact on regulatory function success, and guide teams through ambiguity and evolving data. This individual will lead global regulatory strategy for one or more programs while influencing and partnering closely with cross-functional stakeholders to shape development plans and ensuring alignment across functions in a dynamic, fast-paced environment.
Consultant, Global Regulatory Affairs CullgenConsultant, Global Regulatory AffairsSan Diego, CAPosition Summary: Our ideal Consultant will bring a high level of strategic thinking paired with a get-things-done attitude, and the ability to apply their experience to manage risk and drive programs forward in a small-company environment. Requirements: 15+ years of industry experience in running global clinical regulatory operations and related activities in addition to successful track record as a regulatory consultant required.
Associate Director/Director, Medical Affairs Strategy SolenoAssociate Director/Director, Medical Affairs StrategySan Diego, California$200,000–$265,000 / yearSupport annual medical planning for PWS; work closely across Medical Affairs functions to develop and monitor execution of overall medical strategy and Medical Affairs tactical plans. $200k - $265k (Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.).