- Abbott (Sylmar, CA)
- …Quality, Compliance , Engineering, within a regulated environment, such as medical device , diagnostics or pharmaceutical industries, to develop the competence ... and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of software regulations and compliance (21 CFR Part… more
- Dignity Health (Sacramento, CA)
- … Staff Service by monitoring and planning for budgets and expenses + Promotes medical staff compliance with regulatory and accreditation agencies by ... **Responsibilities** + Ensures a high quality medical staff by thoroughly investigating and verifying the...Spine Center of Excellence Primary Stroke Center, Ventricular Assist Device , and Chest Pain Certification. Other accolades include CMS… 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 ... Science or other relevant engineering/technical degree and 10 years' experience in the medical device industry or a Master's Degree and 8 years' experience… more
- Abbott (Sylmar, CA)
- …ensure the reliability and scalability of our applications that support our life-changing medical device software. You'll work closely with developers, QA, and ... CI/CD pipelines that support traceability, automated testing, and documentation for regulatory compliance . + Help design, implement, and deploy cloud-based… more
- Globus Medical, Inc. (San Diego, CA)
- …+ 1-3 years of mechanical design engineering experience preferably in the medical device field + Bachelor's degree in Mechanical Engineering required. ... At Globus Medical , we move with a sense of urgency...compliance with Globus quality system and other applicable regulatory bodies + Partnering with marketing and product managers… more
- Cordis (Santa Clara, CA)
- …quality assessments and collaborate with suppliers to improve product quality. + Support regulatory compliance by ensuring adherence to FDA and other relevant ... Degree and 3+ years of relevant experience. **Preferred Qualifications** + Medical device /pharmaceutical field, or equivalent combination of education and… more
- J&J Family of Companies (Irvine, CA)
- …MDR, MEDDEV, ). . Clinical/ medical background is a plus. . Medical device experience is highly preferred. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, ... Clinical R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access,… more
- Abbott (Alameda, CA)
- …is located in Alameda, California.** **What you'll do:** + Conduct single or multi-center medical device clinical studies. + Perform study site visits (SQV, SIV, ... of relevant experience in site monitoring. + Experience in conducting medical device and/or _in-vitro_ diagnostics studies preferred. Pharmaceutical background… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and review/approve Gilead and CMO APQRs for commercial products. + Accountable for medical device / combination product quality compliance : engage/liaise with ... Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/ compliance /posters/eppac.pdf) YOUR RIGHTS UNDER THE FAMILY AND MEDICAL… more
- Medtronic (Northridge, CA)
- …teams to ensure compliance with ISO 10993 standards and global medical device regulations. The role also supports product development by designing ... testing with external laboratories, and analyze test results to ensure regulatory compliance . + Perform technical feasibility and design verification… more