Director Quality Assurance Regulatory Affairs (Carlsbad)
BioTalentCarlsbad, CA, United Statesjob_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionDefine regulatory pathways for new products and product changes (e.g., Letter to File, 510(k) submissions). Coordinate with regulatory consulting partners to prepare and execute 510(k) submissions for Class II devices . Maintain oversight of labeling, documentation, and regulatory assessments throughout the product lifecycle. Review design documentation & support development of V&V protocols to confirm conformance to specifications, standards, and process controls using statistically valid methods. Oversee data collection and reporting for V&V results, software validation, hardware testing, and performance testing protocols. Oversee management of Nonconforming Materials (NCMR) , Corrective and Preventive Actions (CAPA), and supplier qualification metrics. Guide creation and implementation of inspection and test methods , improving manufacturing quality, product assembly, and inspection integrity. Contribute to building and maintaining the Design History File (DHF) and Device Master Record (DMR) . Lead document control and change order management across the organization. Bachelors degree in engineering, life sciences, or related field (advanced degree preferred). 10+ years in the medical device industry , with at least 5 years in a leadership role. Deep knowledge of FDA / QSR, ISO 13485, ISO 14971 and related international standards. Experience leading 510(k) preparation and submissions for Class II devices. Technical proficiency in MS Office, Matlab, PLM systems (Agile) , and application of statistical techniques. Strong interpersonal, leadership, and communication skills to influence across departments and drive compliance.
Director of Quality & Regulatory Affairs Medical Devices
📍 Location : North San Diego | 💼 Full-time | 🏥 Medical Device Industry
We are seeking a Director of Quality & Regulatory Affairs to provide strategic leadership and oversight of compliance, regulatory, and quality activities for our breakthrough medical technologies. This is a high-impact role responsible for ensuring patient safety, regulatory success, and operational excellence as we bring innovative devices to market.
Compliance & Risk Management
- Act as Management Representative of the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA Quality System Regulation (QSR) , and global standards for sterile implantable and electronic devices.
- Lead Risk Management activities per ISO 14971 , guiding the Risk Management Team in assessing product changes and monitoring design / development activities for compliance with design controls.
- Manage internal audits , post-market surveillance, regulatory notifications, and customer communications related to complaints and investigations.
Regulatory Affairs
Design Verification & Validation (V&V)
Quality Assurance & Operations
Qualifications
serp_jobs.job_alerts.create_a_job
Director Quality Assurance • Carlsbad, CA, United States
Job_description.internal_linking.related_jobs
Associate Director / Director, CMC Regulatory Affairs.Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the q...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Quality Assurance Manager (Depot) in San Diego, CA.Three Saints Bay, LLC, and a Federal Government Contractor industry leader, is seeking a Quality Assurance Manager (Depot) in San Diego, CA.High S...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
Director of Quality & Regulatory Affairs – Medical Devices.Location : North San Diego | 💼 Full-time | 🏥 Medical Device Industry.
We are seeking a Director of Quality & Regulatory Affairs to provide...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Director, Quality Assurance (GCP).Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tum...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Senior Director Of Accreditation, Regulatory And Contracts - Healthcare.Mission Healthcare, located in seven states, is the largest home health and hospice company in the western United States.We h...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where they will be responsible for guiding strategy, identifying risks, interpreting regulations and ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
MUST HAVE RTE EXPERIENCE AND EXPERIENCE WITH RTE COMPLIANCE!!!.The Director of Quality and Food Safety will provide leadership and is accountable for the development / growth of overall Quality Syste...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
A company is looking for a Director of R&D.Key Responsibilities Develop and execute the company's long-term R&D and innovation strategy Oversee the entire product development lifecycle from conc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
Manager, Design Quality Assurance Continuous Improvement.Manager, Design Quality Assurance Continuous Improvement, is responsible for leading strategic and results-driven Continuous Improvement i...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 A company is looking for a Quality & Regulatory Manager to oversee its Quality Management System and ensure regulatory compliance.
Key Responsibilities Lead and manage regulatory submissions, incl...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours 
Manager / Associate, Director, GMP Quality Assurance.Manager / Associate Director of GMP Quality Assurance will be responsible for quality oversight for GMP activities to support third party manufact...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health indust...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Arrowhead Pharmaceuticals, Inc.Nasdaq : ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them.Using a bro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Director of Quality & Regulatory Affairs Medical Devices.Location : North San Diego | 💼 Full-time | 🏥 Medical Device Industry.
We are seeking a Director of Quality & Regulatory Affairs to provide ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days A company is looking for a Director, Quality Improvement HEDIS Operations.Key Responsibilities Lead and direct process improvement activities for HEDIS operations Collaborate with the Medicare S...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours A company is looking for a Director, Regulatory Affairs, Dx / CDx and Medical Devices.Key Responsibilities Develop and implement regulatory strategies for diagnostics and medical devices to support...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 A company is looking for an Associate Director, BOSE - Process, Training & Execution.Key Responsibilities Developing and implementing quality assurance strategies and processes for clinical trial...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30 Assistant Director, GxP Quality Systems (QA Vendor Management).Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days 
This position is part of the Central Quality team and reports to the Sr Director of Quality Engineering.The role is responsible for software quality across STS and Incada and serves as a member of ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
- serp_jobs.job_card.promoted
Associate Director / Director, CMC Regulatory Affiars
Ionis BrandCarlsbad, CA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Remote Finance Director - AI Trainer
Data AnnotationTemecula, Californiaserp_jobs.filters.remote
serp_jobs.job_card.full_time +1
- serp_jobs.job_card.promoted
Quality Assurance Manager (Depot) (5229)
Three Saints BaySan Diego, CA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Director Quality Assurance Regulatory Affairs
BioTalentCarlsbad, CA, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Director, Quality Assurance GCP
Crinetics PharmaceuticalsSan Diego, CA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Senior Director of Accreditation, Regulatory and Contracts - Healthcare
Mission HealthcareSan Diego, CA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Director, Regulatory Affairs - Gene Therapy
InsmedSan Diego, CA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.new
Director of FSQA
GpacSan Diego, California, United Statesserp_jobs.job_card.full_time
serp_jobs.filters_job_card.quick_apply
- serp_jobs.job_card.promoted
Director of R&D
VirtualVocationsEl Cajon, California, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Sr Manager, Design Quality Assurance - Continuous Improvement
Insulet CorporationSan Diego, CA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Quality & Regulatory Manager
VirtualVocationsOceanside, California, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Sr. Manager / Associate, Director, GMP Quality Assurance
Gossamer BioSan Diego, CA, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Senior Quality Director
Boston ScientificCarlsbad, CA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Associate Director / Director, Drug Safety (Medical Safety Reviewer)
Arrowhead PharmaceuticalsSan Diego, CA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Director Quality Assurance Regulatory Affairs (Carlsbad)
BioTalentCarlsbad, CA, USserp_jobs.job_card.full_time +1
- serp_jobs.job_card.promoted
- serp_jobs.job_card.new
Director of Quality Improvement
VirtualVocationsChula Vista, California, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Director of Regulatory Affairs
VirtualVocationsChula Vista, California, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Senior Quality Assurance Manager
VirtualVocationsEl Cajon, California, United Statesserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Assistant Director, GxP Quality Systems (QA Vendor Management)
Ionis BrandCarlsbad, CA, USserp_jobs.job_card.full_time
- serp_jobs.job_card.promoted
Director of Software Quality
BD MexicoSan Diego, CA, United Statesserp_jobs.job_card.full_time