- ThermoFisher Scientific (Carlsbad, CA)
- …attention to detail + In-depth understanding of relevant regulations eg ICH/GCP, FDA guidelines, etc. + Strong computer skills to effectively use automated systems ... and computerized applications such as Outlook, Excel, Word, etc. + Capable of independently managing clinical only studies. Working Conditions and Environment: + Work is performed in an office environment with exposure to electrical office equipment. +… more
- Abbott (Pomona, CA)
- …managing projects through the phase gate process while ensuring compliance with FDA , ISO 13485, and other international standards. The Project Manager will play ... a key role in driving product strategy, execution, and continuous improvement of project management processes. **What You'll Work On** + Developing, monitor and control the execution of project tasks, deliverables, dependencies and resource requirements. +… more
- Curtiss-Wright Corporation (Santa Clarita, CA)
- …function and design parameters + Extensive experience with SolidWorks, including FEA and FDA add-ons (thermal, vibration, shock, fluid flow) + VPX & VME Electronics ... Packaging experience + Extensive experience in Geometric Dimensioning and Tolerance to ASME Y14.5. + Design leadership and mentoring of less Senior Mechanical staff and the ability to delegate tasking to achieve program design objectives + Experience in… more
- Actalent (Alameda, CA)
- …processes related to managing vendors, partners, and suppliers. + Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & ... 211, US and EU regulations, ICH guidelines, and other industry standards. + Strong written and oral communication skills. + Proven organizational skills to obtain data across multi-functional groups and present results clearly. Additional Skills &… more
- Hologic (San Diego, CA)
- …inclusive of disability and veterans._** **_\#LI-PR1_** **_Must follow all applicable FDA regulations and ISO requirements._** **_Hologic is an equal opportunity ... employer inclusive of female, minority, disabled and veterans, (F/M/D/V)_** more
- ZOLL Medical Corporation (Sacramento, CA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- Actalent (Irvine, CA)
- …and interpret CAD drawings. + Experience interacting with regulatory agencies like FDA , MoH, TUV. + Thorough understanding of US and International Medical Device ... Regulations. + Strong knowledge of Quality Concepts such as CAPA, Audits, and Statistics. + Project management skills and ability to manage multiple tasks simultaneously. + Advocacy for product excellence and quality. + Ability to work cross-functionally with… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties and Responsibilities:** ... + Schedules patients for research visits and procedures. + In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication… more
- Affordable Care (San Diego, CA)
- …insertions + Tally time sheets in an accurate and timely manner and give to FDA for dentist approval and signature + Assist treating dentist with surgery + Take and ... develop x-rays as needed (has certification, where certification is required) + Consistently sterilize instruments with minimal direction, including impression trays and hand piece burs and wipes down equipment after each patient + Escort each patient to the… more
- J&J Family of Companies (Santa Clara, CA)
- …environment. + Experience with designing and developing products in an FDA or other regulated industry. **Preferred Knowledge/Skills, Education, And Experience:** + ... 2+ years of engineering management experience, preferably with complex mechanical or electro-mechanical systems. + Ability to lead and drive outcomes across a matrix environment. + Experience with the development of robotic and or laparoscopic surgical tools… more
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