- ThermoFisher Scientific (San Francisco, CA)
- …and troubleshooting, ensuring compliance with SOPs, safety guidelines, and regulatory expectations. + Provide expertise in microbiological method qualification and ... inspection readiness related to contamination control, including communicating during regulatory inspections. **Required Qualifications** 6+ years of relevant experience… more
- CommonSpirit Health (Santa Maria, CA)
- …violations or exceptions, to the study sponsor and IRB as required by GCP, FDA , OHRP and CommonSpirit Health policy. + In conjunction with the PI and other ... provider/facility. + Prepare, manage and submit all required any required study/ regulatory , documents, applications and forms, including but not limited to the… more
- Medtronic (Northridge, CA)
- …Execution + Own the on-time delivery of software releases that meet regulatory , security, and performance requirements. + Establish best practices for release ... and operational excellence. + Collaboration & Compliance + Partner with product, regulatory , security, and device engineering teams to ensure compliance with FDA… more
- Integra LifeSciences (Irvine, CA)
- …execution of documentation, change control, and training processes based on business, regulatory and customer requirements to ensure compliance with company and ... regulatory requirements. **DUTIES & RESPONSIBILITIES** + Initiates and executes...to document and change management for internal and external ( FDA , BSI, etc.) audits as needed + Investigates and… more
- Philips (San Diego, CA)
- …integration and V&V, ensuring compliance with medical device standards and global regulatory requirements. + You will develop and execute engineering strategies and ... medical device environment: demonstrating practical knowledge and experience with global regulatory requirements and industry standards (eg, IEC 60601, IEC 62304,… more
- Actalent (Valencia, CA)
- …reviews, testing, debugging, and documentation to meet product requirements and regulatory standards. + Contribute to continuous improvement of development processes ... and tools. + Support verification, validation, and regulatory documentation activities as required. Essential Skills + Solid understanding of software engineering… more
- J&J Family of Companies (Santa Clara, CA)
- …to ensure that they comply with applicable procedures standards and regulatory requirements. Additional responsibilities may include but are not limited to ... process nonconformances. + Support internal audits and external audits by regulatory agencies, as required. + Provide expertise in non-product software validation… more
- J&J Family of Companies (Santa Clara, CA)
- …techniques for evaluations. + Collaborate with R&D, Marketing, Medical Safety, Regulatory Affairs, Clinical Engineering, and Quality Engineering to design, evaluate, ... including research, planning, risk assessment, user interface requirements, and regulatory submissions. + Demonstrated ability to negotiate with stakeholders and… more
- Aerotek (San Diego, CA)
- …documents for shipping, maintaining records, and ensuring compliance with regulatory requirements. **Responsibilities** + Prepare documents and instructions to ... and shipping charges. + Ensure documentation complies with governmental and regulatory agencies requirements. + Schedule and coordinate shipment deadlines with… more
- Abbott (Sylmar, CA)
- …strategy for Digital Solutions + Ensure compliance with all applicable standards and regulations (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, EU MDR) + ... improvement **Qualifications** + Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field (Master's or RAC certification preferred)… more