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.
NewSenior Quality Engineer-New Product Dev- CA Synchron Inc.Senior Quality Engineer-New Product Dev- CASan Diego, CA$130,000–$150,000 / yearAs Senior Quality Engineer (New Product Development), you will serve as the Quality lead across Synchron’s product development programs, partnering with R&D, Systems Engineering, Clinical, Regulatory Affairs, Manufacturing Engineering, and Operations to ensure quality is built into products from concept through commercialization. 7+ years of Quality Engineering experience in an FDA-regulated medical device environment with demonstrated experience supporting new product development, design controls, risk management, verification & validation, and design transfer.
NewSenior Quality Engineer I RXSIGHT INCSenior Quality Engineer IAliso Viejo, CAThe Senior Quality Engineer I will be responsible for establishing documentation control and approval workflows to support manufacturing and testing for processes, test methods, test results, batch records, etc. for manufacturing and collaborate with Product Development, Manufacturing, and other cross-functional teams to ensure product quality and regulatory compliance. The Senior Quality Engineer I will support all RxSight products and will be expected to apply knowledge of process engineering, risk management, and quality engineering techniques to innovate and improve quality system processes while simultaneously ensuring conformance to applicable regulatory requirements.
NewEngineer, Combination Devices (Technical Lead) Arrowhead PharmaceuticalsEngineer, Combination Devices (Technical Lead)San Diego, CA$120,000–$145,000 / yearThis individual will partner closely with cross-functional teams, including Product Development, Packaging, Manufacturing, Clinical Development, Supply Chain, Commercial, Quality, and Regulatory Affairs, to ensure combination products are developed in accordance with applicable regulatory requirements and meet patient needs. 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.
NewSupplier Quality Engineer III Alphatec SpineSupplier Quality Engineer IIICarlsbad, CA$110,000–$125,000 / yearThe SQE III partners closely with Supply Chain, Purchasing, Operations, R&D, Manufacturing Engineering, Regulatory Affairs, and Quality teams to ensure supplier performance supports business objectives, regulatory compliance, product quality, and supply continuity. Job Description The Supplier Quality Engineer (SQE) III is responsible for leading supplier quality activities and driving the quality performance of external product and service suppliers used in spinal orthopedic implants, instruments, software, and capital equipment.
NewQuality Engineer III INOVIO PHARMACEUTICALS INCQuality Engineer IIISan Diego, CAThis position independently manages complex quality engineering assignments, including nonconformance investigations, material review and disposition, corrective and preventive actions, supplier quality, change control, quality-system documentation, inspection methods, and continuous improvement initiatives. The Quality Engineer III provides quality engineering leadership and technical support for INOVIO’s electromechanical medical devices and combination products throughout manufacturing, testing, release, and post-production quality activities.
NewQuality Systems Engineer XLR8 EMSQuality Systems EngineerSan Diego, CAThe position is focused exclusively on quality system management, compliance, audits, document control, CAPA administration, training compliance, and certification maintenance, and does not have responsibility for manufacturing process quality, supplier quality, inspection activities, or product quality engineering. The Quality Systems Engineer is the primary owner and administrator of the XLR8 EMS Quality Management System (QMS).
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.
Associate Labeling Specialist – Regulatory Affairs Applied MedicalAssociate Labeling Specialist – Regulatory AffairsRancho Santa Margarita, California$71,000–$80,000 / yearThe Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
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.
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 Specialist – Premarket Regulatory Affairs (Global) Applied MedicalAssociate Specialist – Premarket Regulatory Affairs (Global)Rancho Santa Margarita, California$70,000–$80,000 / yearOur unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions. Position Description: Join Applied Medical as an Associate Specialist in Premarket Regulatory Affairs and help shape the future of medical innovation across our global markets.
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.
Regulatory Affairs Specialist - Vascular (on-site) AbbottRegulatory Affairs Specialist - Vascular (on-site)Temecula, South CarolinaOur extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities.
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.
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.
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.
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.
Sr Regulatory Affairs Specialist DexComSr Regulatory Affairs SpecialistSan Diego, CaliforniaRegulatory 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.