- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. **Key Responsibilities:** + Coordinates data ... to detail and outstanding organizational skills. + Proficiency in data management software and tools. + Excellent written and verbal communication skills. + Ability… more
- ZOLL Medical Corporation (San Bernardino, CA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- Integra LifeSciences (Irvine, CA)
- …issues related to document and change management for internal and external ( FDA , BSI, etc.) audits as needed + Investigates and resolves non-conformances, audit ... + Ability to quickly adapt and navigate different applications and computer software + Solid presentation skills + Ability to communicate with multiple levels… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …archives Manufacturing log sheet records. + Demonstrate processes during audits, including ISO, FDA and internal audits. + Follows all safety rules. + Must be able ... Reg. Blood Borne Pathogen Training. Intermediate knowledge of Microsoft Office software . Attention to detail, good organizational skills and team-oriented. Ability… more
- Philips (San Diego, CA)
- …project management approaches across a multidisciplinary R&D team (hardware, embedded software , algorithms, single-use devices, etc.), that aligns with program goals ... industry standards (eg, IEC 60601, IEC 62304, IEC 62366, UL, ANSI, ASTM, ISO, FDA ). + You must be able to successfully perform the following minimum Physical,… more
- Abbott (Alameda, CA)
- …levels of the organization. + Ensure all automation processes comply with FDA , ISO 13485, and other relevant regulatory standards. + Maintain detailed documentation ... of data analytics tools (eg, Power BI, Tableau) and project management software (eg, Jira, MS Project). **Preferred Qualifications** + RPA certifications (eg, UiPath… more
- Charles River Laboratories (Hollister, CA)
- …prioritize and re-evaluate priorities as situations change. Working knowledge of computer software (MS Word, MS Excel and databases) preferred. The salary range for ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- J&J Family of Companies (Santa Clara, CA)
- …for the treatment of calcified plaque. **Position Overview** In compliance with FDA , European MDD/MDR & ISO regulations, the Document Control Specialist II will ... format and standards + Review, process, and release documents using variety of software packages. + Maintain electronic files of master active or archived documents… more
- Medtronic (Los Angeles, CA)
- …Medtronic Diabetes R&D team contributes directly to this mission; we deliver software and firmware for Medtronic's pump and continuous glucose monitoring devices. ... Experience with Oracle Agile, Trackwise and/or PowerBI systems + Experience in FDA , Certifying Body and/or Notified Body audits/inspections + Experience or training… more
- Actalent (Irvine, CA)
- …user populations to ensure appropriate substantiation. + Utilize Pepper Flow software to manage and maintain traceability of claims to source documentation. ... or Regulatory Affairs within the medical device industry. + Strong understanding of FDA regulations and other relevant standards. + Experience with Pepper Flow or… more