- Cytiva (Pensacola, FL)
- …Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device , Biopharma, or other FDA or EPA-regulated ... Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management… more
- Beckman Coulter Diagnostics (Miami, FL)
- …regulations and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union ... Medical Device Directives (MDD), and In-Vitro Medical ...devices , engineering, or quality assurance.Strong knowledge of Quality, Regulatory compliance, and operations systems and processes, including GMP… more
- Cytiva (Miami, FL)
- …product lifecycle management systems, in biotech, pharma, drug product, or medical device document control experience preferredStrong foundational knowledge in ... as related to compliance with internal and external quality and regulatory standards. Assist with the implementation of standard operating procedures to… 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 ... Description:** Johnson & Johnson is hiring for a **Sr. Manager, Regulatory Compliance - Shockwave Medical ** to join our team located in **Santa Clara, CA.** At… more
- Takeda Pharmaceuticals (Boston, MA)
- …patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager) Plasma-Derived Therapies ... Global Device Sub team to ensure that regulatory device labeling requirements are met for...and/or high complexity products (including combination, Software as a Medical Device , and standalone medical … more
- Caldera Medical (Westlake Village, CA)
- …your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide ... provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ MS preferred, BS or comparable required + Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven ... medical devices (Software as a Medical Device...years of experience with Artificial Intelligence / Machine Learning-enabled medical devices + Expert in Regulatory… more
- Abbott (St. Paul, MN)
- …+ Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices . + Experience of working within ... + Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements...years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification… more
- Abbott (Santa Clara, CA)
- …knowledge of US FDA Medical Device Regulatory Requirements for class III medical devices and EU Medical Device Regulations for new and on ... quality of life through the design and provision of device and management solutions for the treatment of structural...initial submissions, deficiency responses and approvals. Working knowledge of regulatory requirements for medical devices … more
- Abbott (Alameda, CA)
- … medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....plus. . Experience with 510(k) applications, PMA supplements, US device regulations, and/ or with EU and other international… more
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