- BeOne Medicines (San Mateo, CA)
- …procedures, as necessary. + Maintains up to date information regarding initiatives by FDA , Health Canada, and other applicable regulatory authorities related to ... **General Description:** The Manager, Regulatory Advertising and Promotion will be responsible for...will also provide strategic support for the preparation of regulatory submissions for advertising and promotional materials. Strong communication… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Other Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Stryker (San Jose, CA)
- …desired **Knowledge / Competencies:** + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA , and International requirements + ... The **Senior Director, Regulatory Affairs** is a key strategist, responsible for... Affairs** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and delivering… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …Audit Strategy:** Define and execute a comprehensive audit strategy aligned with global regulatory expectations ( FDA , EMA, MHRA, PMDA, PIC/S) and Kite's quality ... long-term career development. The Director ensures compliance with global regulatory requirements, marketing authorization holder expectations, and internal quality… more
- Bayer (Berkeley, CA)
- …customers as well as internal auditors/inspectors; + Ensures conformance to all regulatory requirements, including those of the FDA and various international ... operations are in full compliance with applicable SOPs, safety guidelines and regulatory expectations; + Provides guidance and risk assessment for the resolution of… more
- BeOne Medicines (Emeryville, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting. Physicians in this… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties… more
- Fujifilm (Sacramento, CA)
- …II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the… more
- Abbott (Alameda, CA)
- …standards of service. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... supply chain teams including policy and procedure development, strategy formulation, regulatory compliance, quality systems and product life cycle planning. +… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. + Conduct code reviews and enforce best practices in software engineering. + Mentor junior… more