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Partners closely with Clinical Development, Safety, Commercial, CMC, Quality, and Legal to ensure aligned and value-generating regulatory strategies. This role requires a highly strategic, scientifically grounded, and commercially savvy regulatory executive who can integrate complex development cons
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
STI) is a private, employee-owned company (ESOP) that provides engineering consulting and product development with a focus on safety. Performs work in a manner consistent with all company policies and safety. Experience in healthcare/medical device sales a plus.
Senior Manager of Clinical Systems and Processes to oversee the design and continuous improvement of clinical operations systems. The ideal candidate will have significant experience in clinical research and a track record of implementing systems that enhance operational efficiency while ensuring co
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. Per standardized clinical protocols, independently provides and documents clinical
The role supports, configures and optimizes Oracle Fusion Cloud PLM within a regulated medical device environment, ensuring compliance with FDA and ISO standards. Candidates should have a bachelor's degree and significant experience in Agile PLM and medical device quality management systems.
A leading medical technology firm is seeking a Senior Systems Test Engineer to define and manage software and system requirements for cloud-integrated solutions. The role emphasizes translating user needs into clear requirements, maintaining traceability, and ensuring compliance with regulations. Th
This position will be responsible for supporting leading one or more subteams in clinical development and/or serving as the clinical lead across multiple clinical trials. Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments
The EHS Specialist will coordinate EHS training programs, manage hazardous waste programs, and ensure compliance with safety regulations including OSHA and EPA. The role requires candidates to have a Bachelor's degree and a minimum of 5 years of related experience in safety and/or environmental resp
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. PAR II/Clinical Medical Assistant I. Independently provides & documents clinical care and associated tasks as
Using patient safety principles develops patient education and nursing/patient support systems for the functional application. Design, develops, and enculturates innovative ways to transform nursing care delivery and patient care systems Serves as the professional practice resource for the Patient C
This contract position will focus on leading and supporting initiatives in design and development, ensuring thorough verification and validation of systems.
The ideal candidate will have a BS degree in Engineering and over 5 years of experience in Systems Engineering, particularly in medical device development. MillenniumSoft Inc is seeking a Systems Engineer III in San Diego, CA to lead technical excellence in product development.
A leading medical devices company in San Diego is seeking a Senior Staff Quality Engineer to lead projects aimed at improving quality compliance in the dispensing implementation process. The ideal candidate will have a Bachelor's degree in engineering and at least 10 years of experience in FDA regul
The Executive Director, Regulatory Strategy Endocrinology is a senior regulatory leader responsible for shaping and driving global regulatory strategy across Company's Endocrinology pipeline, spanning early development through commercialization. This role requires a highly strategic, scientifically
Specific responsibilities will include: being the clinical or program lead for the development of clinical research strategies, clinical development plans, and independent direction of Phase 1-4 clinical studies collaboratively within cross-functional project teams (including clinical operations, pr
Lead the development and execution of clinical development strategies for obesity and metabolic disease programs across multiple stages of development. Provide medical and scientific leadership for clinical trial design, execution, and interpretation, including endpoint selection, patient population
The Senior Specialist works collaboratively with operational leaders, quality, patient safety, risk management, and system partners to support improved clinical outcomes, operational performance, regulatory compliance, and patient safety. The Senior SpecialistPerformance Improvement-Licensing and Ac