regulatory-submissions jobs in San Diego

Associate Director of Technical Operations at a biopharmaceutical company overseeing CMC (Chemistry, Manufacturing, and Controls) strategy for a diverse portfolio of small-molecule drugs in development through commercialization. Leads external manufacturing partners (CMOs), manages technology transfer and scale-up activities, ensures cGMP compliance, and authors regulatory submissions.…See more Requires 8+ years of progressive CMC and drug development experience with demonstrated leadership across multiple CMC disciplines and small-molecule, peptide, and biologic manufacturing.

Sr. Research Associate will design and execute design-of-experiments (DOEs) to optimize surface chemistry processes for in vitro diagnostic systems, transitioning formulations from R&D through pilot scale-up and manufacturing under GMP/FDA design control.…See more The role requires hands-on expertise in fluorescence imaging/spectroscopy, microfluidics, molecular biology techniques (nucleic acid extraction, PCR, amplification), and consumable characterization—including test method design, acceptance criteria definition, and root-cause analysis. The candidate will author technical documentation (protocols, batch records, DHF submissions), collaborate cross-functionally with assay development, reagent chemistry, device engineering, manufacturing, and quality/regulatory teams, and support FDA submissions (510(k)/PMA, CE-IVDR). Strong systematic troubleshooting, laboratory skills, and ability to present data to leadership are essential.

Sr Staff QA Engineer at Dexcom leading Design Quality Engineering for material characterization, formulation science, and material-related risk management across product lifecycle. Responsibilities include establishing traceability between material attributes and device performance, leading qualification strategies for polymers, enzymes, reagents, adhesives, coatings, and membranes, applying ISO 14971 risk management, and partnering with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs.…See more Requires 8+ years in medical device, pharmaceutical, biotechnology, or combination product development with deep expertise in material characterization, analytical chemistry, and formulation development.

Sr Staff QA Engineer at Dexcom leads Design Quality Engineering for material characterization, formulation science, and material-related risk management across product development and lifecycle management. The role requires deep expertise in characterizing complex material systems (polymers, enzymes, reagents, adhesives, coatings, membranes) and establishing traceability between material attributes, manufacturing processes, and finished device safety/performance.…See more Responsibilities include driving risk-based decision making using ISO 14971, overseeing qualification strategies, partnering with R&D and regulatory teams, and representing Design Quality in design reviews, audits, and regulatory submissions. Requires 8+ years in medical device, pharmaceutical, or biotechnology quality engineering with demonstrated experience in material characterization and design control processes.

Lead software development for an FDA-cleared blood testing platform, overseeing instrument software, application software, cloud connectivity, cybersecurity, and software quality systems. Manage the full software development lifecycle including requirements, risk management, design controls, verification and validation, and regulatory compliance.…See more Work closely with Quality and Regulatory Affairs on FDA submissions, audits, documentation, and post-market support. Direct strategy, roadmap planning, architecture, and release management for a regulated in vitro diagnostic (IVD) medical device.