- BeiGene (San Mateo, CA)
- **General Description:** BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent ... for development of strategies, planning, drafting, and managing CMC-related regulatory submissions to meet aggressive timelines. The individual will provide… more
- Abbott (Santa Clara, CA)
- …lab results for millions of people. **What You'll Work On** We are recruiting for a SENIOR MANAGER REGULATORY AFFAIRS to join the Regulatory ... + Bachelor's Degree in life sciences, engineering, other technical discipline, or Regulatory Affairs + Minimum of 9 years of related work experience + Provides… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC, is responsible for developing and implementing global regulatory CMC ... degree. **Experience:** + Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience in… more
- The Clorox Company (Pleasanton, CA)
- …will possess a deep understanding of digital technology, data management, and regulatory affairs within the CPG industry, coupled with strong leadership ... **What we look for:** + Bachelor's degree in Computer Science, Information Technology, Regulatory Affairs , or a related field. Master's degree preferred. +… more
- Stryker (Fremont, CA)
- …from division Global Customer Excellence, Global Commercial Excellence and Clinical Affairs senior leadership. + Ensures strategic alliances with physicians, ... external/internal sources and partners with other functions such as Clinical Operations, Medical Affairs , Regulatory Affairs and Marketing to obtain … more
- Veterans Affairs, Veterans Health Administration (Palo Alto, CA)
- …activities are in compliance with standards issued by various accrediting and regulatory groups; * Develop plans (with target completion dates) to ensure that ... such as director of a regional office, medical facility or program manager . An individual's total experience, education and volunteer work experience must… more
- Abbott (Santa Clara, CA)
- …methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and ... and exchange of documents between stakeholders (eg, internal personnel such as Regulatory Affairs , R&D, Clinical R&D, Sales and Marketing, Library Services,… more
- Abbott (Santa Clara, CA)
- …Sciences; Advanced degree(s) in biomedical science, medicine, nursing, clinical/mechanical engineering, regulatory affairs , or related fields + Full professional ... technical/medical/ regulatory writing experience, risk management, biomedical/clinical research, regulatory affairs , clinical/quality/R&D engineering, or other related… more
- Microsoft Corporation (Mountain View, CA)
- …the European Union + Experience working on radiology and imaging devices + Regulatory Affairs Certification (RAC) Devices, lead ISO13485 auditor, or equivalent + ... with a technical background and a customer-driven passion for regulatory work, to join our team. This is an...place for you. We are looking to hire a Senior Program Manager to join our team.… more
- BeiGene (San Mateo, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... regular updates on study progress in the region to senior management and Global Clinical Study Manager ...region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input… more
- BeiGene (San Mateo, CA)
- **General Description:** The Senior Manager of R&D Quality Systems, Strategy, and Excellence (QMS) is responsible for implementing and maintaining a balanced, ... partnerships with key business stakeholders, including Clinical Operations, Clinical Development, Regulatory Affairs , Data Management, Biostats, GPS, RBQM, etc.… more
- BeiGene (San Mateo, CA)
- **General Description:** The Senior Manager of R&D Quality Systems, Strategy, and Excellence (Process & Procedure) is responsible for implementing and ... across teams. + Build strong partnerships across departments (eg, Clinical Operations, Regulatory Affairs , R&D) to ensure that quality is embedded throughout… more
- Stryker (Fremont, CA)
- …will work closely with cross-functional teams-including R&D, marketing, sales, and regulatory affairs -to ensure successful launches and maximize market adoption ... (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) We are seeking an experienced and highly motivated Senior Global Portfolio Manager to join our… more
- Edwards Lifesciences (San Jose, CA)
- …and healthier lives. Join us and be part of our inspiring journey. As ** Senior Manager , Biostatistics, TMTT** , you will use your expertise as biostatistical ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
- Abbott (Santa Clara, CA)
- …+ Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interacts with regulatory ... + Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality… more
- Abbott (Pleasanton, CA)
- …stakeholders. + Keep commercial organization and other internal functions (eg, Clinical, Regulatory Affairs , R&D) informed about the potential impact of key ... models for various technologies and will coordinate extensively with Marketing, Clinical Affairs , Regulatory , Sales and other functions to develop and… more
- Reyes Holdings (San Leandro, CA)
- …Excellent project management skills + Experience working with cross-functional teams + Excellent Regulatory Affairs skills + Expert Regulatory Knowledge ie, ... Manager is the subject matter expert for scientific, regulatory , technical, food safety and/or quality related to Company....risk and meet system goals + Provide information to senior management for decision making during a crisis situation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …biopharmaceutical /pharmaceutical CMC development and commercial teams, GMP environment and regulatory affairs + Prior experience in project management required; ... Manager , Project Management** **Location: Foster City** **Specific Responsibilities:** The Senior Project Manager in PDM Portfolio Strategy and Operations… more
- Abbott (Pleasanton, CA)
- …+ Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality ... to restore their health and live full lives. The ** Senior Clinical Research Scientist** is a member of the... regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. +… more
- Stanford University (Stanford, CA)
- …regulatory requirements, or experience working with an IRB. + Knowledge of regulatory affairs , including FDA regulations, IRB review and approval process, and ... quality, education and business development managers. You will collaborate closely with the senior research manager , CEC, to train staff and ensure we can… more