- Amazon (Sunnyvale, CA)
- …products to various international approval agency * Prior experience with test and analysis methodologies and test equipment used for regulatory compliance tests ... Description As Manager of Regulatory Compliance Engineering, you will lead a team...of individual contributors and technical leads responsible for ensuring regulatory compliance across Amazon's growing portfolio of products. You… more
- Abbott (Sylmar, CA)
- …+ Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues + Perform risk assessment or analysis + Lead functional ... Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm...CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of… more
- Amazon (Sunnyvale, CA)
- …internal interdisciplinary teams to drive key aspects of compliance requirement, design analysis , and compliance test. You must be responsive, flexible, and able to ... ambitious and complex compliance challenges through research, engagement with regulatory agencies, hands-on testing, debugging, and validation activities. You must… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ideal candidate will possess deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA), and life sciences Quality Management and Batch ... solutions that can adapt to evolving business requirements and regulatory landscapes. + Conduct detailed gap analyses and propose...+ Master's Degree and 6 Years' Experience OR + PhD + 8+ years of experience with SAP, specifically… more
- BeOne Medicines (San Mateo, CA)
- …**Risk Assessment, Regulatory Inquiries, and Periodic Reporting** + Lead the analysis of safety data and author relevant safety sections of global regulatory ... applicable safety documents or safety section of clinical or regulatory documents. + Support strategy development, analysis ,...and PowerBI **Other Qualifications:** + PharmD, NP, RN, or PhD in a medical field or biological science and… more
- Abbott (Sylmar, CA)
- …to provide biocompatibility strategy and deliverables in compliance with global regulatory requirements such as ISO 10993. Additionally, this role requires knowledge ... Class III). This individual must have strong ability to interpret biocompatibility regulatory requirements and guidance and apply regulatory requirements as… more
- Medtronic (Irvine, CA)
- …specifications and directions to the clinicians/statistical programmers. + Supports the regulatory review and approval of the experimental therapies. + Partner in ... track, and manage potential problems. + Writes the statistical analysis plan for the study, if required. + Takes...relevant questions from FDA, FDA Advisory Panels, and/or other regulatory agencies, and in negotiations with regulatory … more
- General Atomics (San Diego, CA)
- …practical support solutions to technical engineering problems in reactor fuel cycle analysis and safety design and operation to support startup, full power ... Interface with the Reactor Design Modeling team to ensure designs meet regulatory and licensing requirements. + Documents findings and communicates reports and… more
- Amgen (Thousand Oaks, CA)
- …data to support drug substance and drug product development, including purity analysis , chiral purity and structure elucidation using mass spectrometry + Manage ... and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. + May lead and develop a small...3 years of Scientific experience OR + Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where… more
- AbbVie (Irvine, CA)
- …drug substance and drug product development. + Experience developing global regulatory strategies including authoring regulatory submissions, and responding to ... position involves multi-disciplinary collaborations across Discovery, Development, Manufacturing, and Regulatory to execute and deliver material and information for… more
Recent Jobs
-
Medical Assistant Certified
- Sea Mar Community Health Centers (Des Moines, WA)
-
Production Supervisor - 1st Shift (28 Degree Room)
- Perdue Farms, Inc. (Lewiston Woodville, NC)
-
Operations Expert
- SAP (Newtown Square, PA)