- United Therapeutics (Sacramento, CA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... in trust and collaboration. You naturally spot the needs of patients and healthcare providers, and you love coming up with thoughtful, strategic ideas that turn… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- **Job Description Summary** Fulfill FDA , ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to ... applicable regulatory bodies. **Job Description** We are **the makers of...Reporting (MDR) + Prepare and submit MDR reports to FDA + Identify problems and lead projects to improve… more
- Fortive Corporation (Irvine, CA)
- …productivity. Ensure all designs and projects are compliant with GMP, FDA , ISO 13485, and applicable regulatory requirements. **Required Qualifications:** ... and develop mechanical systems and components to meet product requirements, regulatory standards, and safety guidelines. Provide mechanical engineering support for… more
- BeOne Medicines (San Mateo, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting._ _Physicians in this… more
- Edwards Lifesciences (Irvine, CA)
- …with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize ... Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across… more
- Fortive Corporation (Irvine, CA)
- …the development and assessment of new technologies for potential products following the regulatory guidelines / standards ( FDA , TGA, ISO, EU MDR etc.). Ensures ... preferred. Professional experience in a GxP-regulated industry and understanding of QSR, FDA , and ISO guidelines is preferred. Working experience with sterilants and… more
- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare , with leading businesses and products in diagnostics, medical...System are developed, validated and maintained in compliance with regulatory and corporate requirements. This is an individual contributor… more
- J&J Family of Companies (Santa Clara, CA)
- …and counter measures. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements (ISO), Company policies, operating ... At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented,… more
- Medtronic (Northridge, CA)
- …can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down ... concise, and well-structured biocompatibility evaluation plans and reports to support regulatory submissions. The Senior Product Engineer applies scientific rigor in… more
- Biomat USA, Inc. (Bakersfield, CA)
- Would you like to join an international team working to improve the future of healthcare ? Do you want to enhance the lives of millions of people? Grifols is a global ... healthcare company that since 1909 has been working to...donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts… more