- Abbott (Alameda, CA)
- …verbal communication skills. + Knowledge of FDA/International guidelines for drug / device safety reporting requirements. Apply Now (https://www.jobs.abbott/us/en) ... role will ensure the Medical Events Group (MEG) is compliant with global medical device reporting regulations. This position will be based out of our Abbott Diabetes… more
- AbbVie (Irvine, CA)
- …and tech transfer. *Ensure proper integration and support of quality regulations: drug , biologics, device and/or combination products. *Assist project teams in ... products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that… more
- Cardinal Health (Sacramento, CA)
- …responsibility (EPR) regulations; and other product-specific environmental / sustainability drug and device lifecycle obligations and stewardship programs. ... and color additive legislation and regulations, and EPR and other drug and device stewardship programs. This entails working with multiple business leaders… more
- Stryker (Irvine, CA)
- …local minimum wage rates. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident ... insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan… more
- Medtronic (Los Angeles, CA)
- …transforms lives Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse ... to meet goals and objectives. Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance Reporting requirements by regulatory bodies… more
- CommonSpirit Health (Santa Maria, CA)
- …conducting clinical trials required; worked as primary research nurse for at least 5 drug or device trials. + Experience in implementation of research protocols ... research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff. + Process labs for clinical… more
- Ascendis Pharma (Palo Alto, CA)
- …technical documents and influencing colleagues across functions. + Experience with drug - device combination products preferred. + Experience in filing regulatory ... our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially… more
- AbbVie (Irvine, CA)
- …safety surveillance + Responsible for safety surveillance for pharmaceutical / biological / drug - device combined products + Lead and set the strategy for ... key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans + Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents + Analyze and… more
- Cordis (Irvine, CA)
- …specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and ... peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. **Responsibilities** As a Senior Business Analyst, you will act as the bridge between our… more
- Norstella (Sacramento, CA)
- …and healthcare service providers, including the top 10 global pharma and CROs. From drug and device discovery and development to regulatory approval, and from ... leading providers of data and intelligence on clinical trials, drug treatments, medical devices and what's new in the...cut through the clutter and make sense of changing drug development, regulatory and competitive landscapes. Now, Citeline is… more