- Terumo Neuro (Aliso Viejo, CA)
- …submissions (preferably as a medical writer for pharmaceutical, CRO, or medical device clients). 4. Excellent writing and editing skills, and attention ... documents and scientific presentations in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, KOLs and...in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, KOLs and physician investigators. + Conducting… more
- Terumo Neuro (Aliso Viejo, CA)
- …(SOPs), regulations, standards, good clinical practices, and guidelines applicable to the medical device industry to contribute to overall quality and ... laws, regulations, standards, good clinical practices, and guidelines applicable to the medical device industry. + Identify gaps and develop and/or standardize… more
- Cordis (Irvine, CA)
- …treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, ... SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions. At Cordis, we're teammates, not just employees. We embrace an… more
- Abbott (Alameda, CA)
- …development is required. **Preferred Qualifications** + Solid knowledge of regulations for medical device development, (EN460001, ISO13485, FDA) is desirable. + ... Embedded UI design experience preferred + Detailed experience with medical device development processes and FDA 510K...device development processes and FDA 510K and PMA regulatory requirement and process is desirable. + Good knowledge… 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 ... design and development. **Essential Job Functions** + Lead the software development for medical device product(s) in full compliance with the company's Design… more
- AbbVie (Irvine, CA)
- …set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans + ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...Apply current regulatory guidance as appropriate for safety surveillance and authorship… 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 ... 10+ years of experience in advanced analytics, AI, or data science within the medical device , medtech, or pharmaceutical industry. + Strong expertise in machine… 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 ... with the company's Design Control requirements and consistent with applicable regulatory requirements. + Ensure proper documentation consistent with the company's… more
- Kelly Services (Irvine, CA)
- …an_ **_R&D Engineer_** _for a long-term contract at one of our_ **_Global Medical Device_** _clients, located in_ **_Irvine, CA_** _._ _Our Client is a_ **_global ... _As a Kelly employee, you will be eligible for Medical & Dental 50%_ **_paid_** _, 401K and a...motivated_** + **_Ability to travel domestic 10%._** + **_Medical device Class II and III_** _experience preferred_ + _Knowledge… more
- Stryker (Irvine, CA)
- …engineering or related discipline. + 4+ years' related experience required. + Medical device industry experience required. + Familiarity with New Product ... Sigma Green or Black belts are preferred. + Experience with the medical device development lifecycle, including risk management and design/process verification… more