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Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submission
Partners closely with Clinical Development, Safety, Commercial, CMC, Quality, and Legal to ensure aligned and value-generating regulatory strategies. Demonstrated expertise in FDA regulatory frameworks and evolving regulatory policy landscape. The Executive Director, Regulatory Strategy – Endocrin
Clinical Concept Mapping: Translate complex clinical concepts and workflows into explicit data element mappings across diverse source systems, ensuring semantic accuracy and clinical validity. Deep clinical domain knowledge including understanding of clinical workflows, medical terminology, and heal
Compliance & Quality Assurance Engineer. Develop, review and accept Quality Assurance Plans (SQAP/HPAP) to ensure certification compliance. Understand, update, and maintain QMS systems in compliance with ISO9001, AS91000, and other equivalent industry standards in addition to ensuring compliance to
Senior Quality Engineer – Design Assurance (Firmware / Electrical Systems). Review verification and validation documentation to ensure regulatory compliance and product quality. Quality Engineering, Design Assurance, Product Quality, or related experience.
Reviews the safety program performance and safety performance on construction projects to ensure compliance with regulatory mandates and current professional practices: recommends and communicates appropriate safety standards and guidelines; verifies the compliance of contractors' safety plan with l
Under the general supervision of a licensed care provider and/or management, the Clinical Medical Assistant I (CMA I)/ Patient Access Representative II (PAR II) is responsible to function as both a CMA I and a PAR II. This position collaborates with interdisciplinary team to ensure optimal care is p
This role will communicate with patients and performs clinical services to ensure high quality patient care in a fast-paced environment. Utilizes electronic health records to order, process and document clinical treatment plans for patient as directed by the provider. Takes patient vital signs and o
Clinical Operations, Clinical Development, Biostats, Data Management, Clinical Pharmacology, and Regulatory Affairs) to ensure compliance and continuous process improvement. Comprehensive knowledge of clinical quality principles and systems, audit, clinical study processes, and procedures within stu
Under the general supervision of a licensed care provider and/or management the PAR II/Clinical Medical Assistant I is responsible to function as both a PAR and a Clinical Medical Assistant. Collaborates with interdisciplinary team to ensure optimal care is provided in a quality environment to patie
This role is crucial in maintaining the Quality Management System in compliance with regulatory requirements like ISO 13485 and FDA standards. Ideal candidates should possess a deep understanding of quality systems and relevant experience in the medical device industry. Ignite Human Capital is seeki
This role involves evaluating risks to employee safety and enforcing robust controls to mitigate hazards in a medical device R&D environment. The ideal candidate will possess expertise in executing SHE risk assessments, lead safety investigations, and develop compliance programs. Roche is seeking a
Balboa Nephrology Medical Group in Chula Vista is seeking a Research Assistant to support the Clinical Research Coordinator with data management and clinical trial tasks. The ideal candidate will have a high school diploma and experience in clinical research. The position offers a comprehensive bene
The ideal candidate will assist with medical record audits, data collection, and performance improvement initiatives to enhance patient safety and regulatory compliance. Aurora San Diego Hospital is seeking a Quality Coordinator to support the Quality and Risk Management Department.
Transport Patients and Items:* Correctly utilizes the transport tracking system for transporting patients and items:* Tracking and progressing jobs* Accepting jobs - limited job rejections* Delay and cancellation of jobs* Uses mini tasks and task assistance when available* Correctly identifies patie
Werfen seeks a Staff Quality Engineer in San Diego to ensure the safety and efficacy of innovative IVD and medical device products. This individual-contributor role requires significant experience in compliance and quality management. Responsibilities include coordinating quality activities across p
General Dynamics - Ordnance and Tactical Systems (CA) in San Diego seeks a Quality Assurance Specialist to evaluate and improve product quality. The ideal candidate will manage internal audits, develop quality assurance procedures, and must possess an Associate's Degree with 5-7 years of related exp
Bachem Holding AG in Vista, California, is looking for a Quality Assurance Manager to maintain and improve its quality system in compliance with FDA and ICH standards. The role involves managing regulatory inspections and ensuring organizational compliance. Ideal applicants should have over 10 years
The ideal candidate will manage internal audits, develop quality assurance plans, and provide guidance on regulatory compliance. A leading IT staffing company is seeking a Quality Assurance Manager to oversee CAPA workstreams and compliance audits. The role requires auditing experience with medical