- Stryker (Modesto, CA)
- …Degree in nursing or clinical requiredMinimum of three (3) years; in medical device clinical capacity or cath lab.Proven understanding of cardiovascular ... teams to provide feedback on device features and new device developmentDocument procedural case observations for regulatory requirements and ongoing… more
- Stryker (San Francisco, CA)
- …Degree in nursing or clinical required + Minimum of three (3) years; in medical device clinical capacity or cath lab. + Proven understanding of cardiovascular ... new device development + Document procedural case observations for regulatory requirements and ongoing continuous improvement + Provide basic ultrasound training… more
- J&J Family of Companies (Irvine, CA)
- …leading Medical /Clinical/R&D teams in a regulated, commercial biomedical or medical device business is strongly preferred 9.) Demonstrated success in ... & Compliance, Health Economics & Market Access, and Professional Medical Education to influence overall regulatory and...and Professional Medical Education to influence overall regulatory and commercial strategy, as well as support product… more
- Abbott (Alameda, CA)
- …discipline. + Must have 5+ experience in Software Quality Assurance. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR ... (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. + Develops and maintains… more
- J&J Family of Companies (Santa Clara, CA)
- …manufacturing, and quality management systems in regulated industry with at least 12 years in a medical device industry. + A minimum of 10 years is required as a ... but not limited to R&D, Supply Chain/Manufacturing, Clinical and Medical Affairs, Regulatory Affairs, Service, Marketing, in...Design and Development including End-to-End Quality & Compliance in Medical Device . + Must have a minimum… more
- Stryker (San Jose, CA)
- …required CERs, and annual updates. + Performs systematic literature reviews for medical device groups or sub-groups. Interprets literature information and ... management software + Knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and… more
- Edwards Lifesciences (Irvine, CA)
- …portfolio of products across TMTT. The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... experience in therapeutic ultrasound research or a PhD (preferred). + Ultrasound based medical device product development is highly preferred. + May serve as… more
- Actalent (Vista, CA)
- …annual reports, control documents, etc. to FDA authorities. + File Vigilance Reports or Medical Device Reports to Competent Authority or FDA. + Review ... Specialist is primarily responsible for overseeing the quality and regulatory aspects of the company. This includes the development...+ Quality Management System (QMS) + Quality assurance + Medical device auditing + CAPA (Corrective and… more
- Stryker (San Jose, CA)
- …Market** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) to ... Microsoft, or similar, demonstrating strong technical skills. + Experience with Software as a Medical Device (SaMD) and Software in a Medical Device… more
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