- Gilead Sciences, Inc. (Foster City, CA)
- …affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory /industry forums for topics of external policy relevance ... Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and… more
- Ascendis Pharma (Palo Alto, CA)
- …with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory ... risk mitigation strategies, and influences project teams and sub teams across international site locations. + Provides regulatory information and guidance for… more
- Abbott (San Diego, CA)
- …risk in the context of risk management. + Knowledge of national and international regulatory compliances and frameworks such as NIST Cybersecurity Framework, ISO ... also have access to: + Career development with an international company where you can grow the career you...into the product lifecycle** , ensuring our devices meet regulatory requirements and protect patient safety. **What You'll Work… more
- Abbott (Alameda, CA)
- …Marketing, Medical Affairs). *Creates/updates technical documents for medium risk product international regulatory submissions (eg, IVDR Class C/D and/or novel). ... above by locating inputs for documents, navigating systems related to international and domestic regulatory submission, labeling, records, and troubleshooting… more
- Abbott (Sylmar, CA)
- …and submission strategies for new FDA 510(k) AI-based SaMD modules. Support international regulatory submissions. + Ensure AI solutions comply with relevant ... also have access to: + Career development with an international company where you can grow the career you... regulatory standards and collaborate with Regulatory Affairs… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …customer satisfaction. + Support the monitoring and interpretation of current and new regulatory requirements and international standards for the US and other ... of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist, you will play a crucial role...regulatory intelligence for projects related to US and international labeling remediation. + Perform gap analysis to support… more
- Abbott (Santa Clara, CA)
- …of the Global Regulatory Landscape: Bring deep knowledge of international regulatory requirements to guide operational decisions. **Qualifications** + ... also have access to: + Career development with an international company where you can grow the career you...study execution. + Drive strategic execution of clinical and regulatory goals across diverse therapeutic areas. + Manage timelines,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …US Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical ... 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
- General Atomics (San Diego, CA)
- …through 7020, and Cybersecurity Maturity Model Certification (CMMC). + Familiar with international regulatory requirements that affect that Aerospace and Defense ... continuous learning with a passion to keep abreast of changes in regulatory and technology environments. + Responsible for observing all laws, regulations, and… more