- Caldera Medical (Westlake Village, CA)
- …ensure the ongoing reliability, compliance , and cost-effectiveness of our existing medical device products. This role is crucial for supporting products ... of experience in a regulated industry, with a strong emphasis on medical device product development or sustaining engineering. Experience with Class II or Class… more
- Abbott (Alameda, CA)
- … Events Group (MEG) and No Product Return (NPR) will lead global medical device vigilance, post-market surveillance, and regulatory reporting for Abbott's ... **What You'll Work On** * Define and implement global medical device reporting and vigilance strategies for...Medical Events Group team, fostering a culture of compliance and continuous improvement. * Manage the No Product… more
- US Tech Solutions (San Bruno, CA)
- …Quality System Regulations, ISO 13485, and integration of best practices from the medical device industry. **Documentation and Support:** 1. Support the creation ... and support CAPA, complaints, audits, and overall QMS functions. **Experience:** ** Medical Device Software Experience:** 1. Proven experience in software… more
- Medtronic (Santa Rosa, CA)
- …+ Bachelor's degree required with a + Minimum of 4 years of experience in medical device regulatory affairs experience + Or Advanced degree with 2 years of ... R&D, Quality, Clinical, and Marketing teams to ensure regulatory compliance throughout the product development process and to resolve...heart valve products + Experience with Software as a Medical Device + RAC Medical … 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 ... or equivalent work experience. . Minimum of 10 years' progressive experience in medical device development, including 3+ years' experience in leading projects in… more
- Caldera Medical (Westlake Village, CA)
- …looking for a strong leader with deep experience in clinical research and medical device /biopharma environments, who can balance strategic vision with hands-on ... are conducted within scope, budget, and timelines. * Ensure compliance with Good Clinical Practice (GCP), ISO 14155, and...? Caldera Medical is a growth stage medical device company dedicated to improving the… 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 ... of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. + A history of...market releases. + Product knowledge including product vigilance and medical device reporting. + High attention to… more
- ZOLL Medical Corporation (Riverside, CA)
- …+ Provide ongoing education and training to hospital and office staff on medical device order requirements and workflows to achieve operational efficiencies. + ... university or equivalent combination of education and experience in sales. + Healthcare/ Medical Device (Clinical or Billing) experience preferred + Experienced… more
- Oracle (Sacramento, CA)
- …and scalable processes. + Serve as the escalation authority for device performance, software/firmware issues, and field incidents. + Author roadmaps, investment ... cases, automation strategies, and device standardization documents. **KEY RESPONSIBILITIES:** + Develop, communicate, and...deliver against project milestones and SLAs, ensuring performance and compliance at every stage. + Drive adoption of IoT… more
- AbbVie (Irvine, CA)
- …in vivo and tissue processing methods to support development of novel medical device /tissue products. + Critically evaluate scientific or regulatory advances, ... (cell biology, molecular biology, pharmacology, immunology, bioengineering, or similar) + Medical device experience or experience in a regulated environment… more