- Gilead Sciences, Inc. (Foster City, CA)
- …Compliance & Risk Management: Ensure all legal technology solutions align with global compliance frameworks (eg, GDPR, FDA , EMA) and company policies. + Team ... driving the strategic implementation of legal technology solutions to enhance efficiency, compliance , and cost management within the legal department. As a senior… more
- Edwards Lifesciences (San Diego, CA)
- …reporting and respond to ad hoc requests from internal stakeholders. + Maintain Regulatory Compliance : Stay current with training and ensure all activities align ... with ACCME, OIG, and FDA guidelines, as well as Global Compliance policies. + Contribute to Continuous Improvement: Participate in process enhancements and… more
- J&J Family of Companies (Irvine, CA)
- …for managing operational aspects of their team (eg, workflow, performance, and compliance ), as well as ensuring achievement of team goals within established ... experience. . Responsible to work cross functional to support regulatory submissions and responses. . Develops actionable insights for.... Knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering . Good knowledge… more
- J&J Family of Companies (Santa Clara, CA)
- …products as subject matter expert on product design, including design changes and regulatory inquiries. + Prototype and develop proof of concept designs and test ... from concept through commercialization. + Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable… more
- Philips (San Diego, CA)
- …and implementing solutions through product development, integration and V&V, ensuring compliance with medical device standards and global regulatory ... medical device environment: demonstrating practical knowledge and experience with global regulatory requirements and industry standards (eg, IEC 60601, IEC 62304,… 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 ... on cybersecurity and AI/ML requirements, oversee implementation, and ensure compliance . + Drive root cause analysis and corrective/preventive actions (CAPA)… more
- Aerotek (San Diego, CA)
- …involves preparing documents for shipping, maintaining records, and ensuring compliance with regulatory requirements. **Responsibilities** + Prepare documents ... and shipping charges. + Ensure documentation complies with governmental and regulatory agencies requirements. + Schedule and coordinate shipment deadlines with… more
- Fujifilm (Sacramento, CA)
- …high level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more
- Fujifilm (Sacramento, CA)
- …to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more
- Bayer (Berkeley, CA)
- …New Product Introduction is beneficial; + Strong understanding of data integrity, regulatory requirements ( FDA , EMA, etc.), and cGMP requirements for ... for the CT-MOD team. Delivers training. Ensures own training is always in compliance . Modifies shift patterns & working hours when needed and at short notice… more