- 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Sr Associate, Regulatory Affairs , CMC** **Foster City, California** ... and document policies and procedures within the CMC regulatory affairs department under supervision of manager . Participates in initiatives internal… 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; ... Join Gilead and help create possible, together. **Job Description** **Title: Sr . Manager , Project Management** **Location: Foster City** **Specific… more
- Gilead Sciences, Inc. (Foster City, CA)
- …areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities ... are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support… more
- Amazon (Sunnyvale, CA)
- …experience in applying technical standards in consumer electronics. Have a strong grasp of regulatory affairs in US and EU and can effectively program manage the ... into the exciting role of Hardware Compliance Technical Program Manager (TPM) at Amazon Lab126! In this role, you'll...legislation and advocacy to passed law. - Experience with regulatory affairs within the hardware industry. 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)
- …medical and surgical specialty services including audiology & speech pathology, dermatology, dental geriatrics, neurology, oncology, podiatry, prosthetics, ... activities are in compliance with standards issued by various accrediting and regulatory groups; * Develop plans (with target completion dates) to ensure that… more
- Abbott (Santa Clara, CA)
- …of a device over its lifecycle. The position reports to the Sr . Manager of Clinical Evaluations Global Regulatory Operations. **What You'll Work On** + ... methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and… 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 ... products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion...prevention of pollution under their span of influence/control The Sr Manager , Biostatistics Level is lateral to… 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
- 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
- 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
- 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
- Stanford University (Stanford, CA)
- …including housing assistance (https://fsh.stanford.edu/) , please contact Raymond Kania, Faculty Affairs and Programs Manager , at ###@stanford.edu . Stanford ... or exemption. The successful candidate will become responsible for senior -level physician executive leadership, administration, and management of the Pediatric… more