- ThermoFisher Scientific (Fremont, CA)
- …and operational excellence experience at scale * Strong working knowledge of cGMP, FDA , and other relevant quality / regulatory requirements . Exposure to ... future leaders . Advanced understanding and ability to adhere to established quality standards and regulatory compliance requirements for medical device or… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …for decision-making. Additionally, it manages regulatory communications such as FDA responses, drives continuous improvement across the quality system, and ... **Job Description Summary** The Quality Systems and Regulatory Staff Lead...FDA warning letters, field action inquiries, and other regulatory correspondence. Ensure timely and accurate updates on mitigation… more
- Sumitomo Pharma (Sacramento, CA)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …[510(k)] and Pre/Q-Sub submissions in a timely manner. Act as liaison with FDA regarding product submissions. + Assess US regulatory requirements for proposed ... **Job Description Summary** The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality , Manufacturing, Global Regulatory Strategy). + Assess and provide … more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …**Primary responsibilities for role:** + Prepares and files complex pre-market and post-market regulatory submissions with the US FDA , Notified Bodies in the EU ... in reducing regulatory risk. + Review, provide regulatory input to, and approve various quality ...solutions to management + Demonstrated ability to communicate with FDA and international customers (eg, regulatory agencies,… more
- GRAIL (Menlo Park, CA)
- …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Abbott (Pleasanton, CA)
- …for regulatory approval of new and modified products. + Prepares robust regulatory applications for FDA and/or international regulatory agencies to ... requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements,...years of experience. + 2-3 years of experience in regulatory preferred but may consider quality assurance,… more
- Terumo Neuro (Aliso Viejo, CA)
- …approval submission activities focused on US/EU/Canada and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and ... **12814BR** **Title:** Associate Principal, Regulatory Affairs **Job Description:** Responsible for establishing and...+ Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as… more
Recent Jobs
-
Software Development Engineer IV, Data Hub
- Premera Blue Cross (Mountlake Terrace, WA)
-
Cloud Solutions Architect - Google Workspace and Identity
- Sabre (Dallas, TX)
-
Sales Associate-ANN
- LOFT (Reston, VA)
-
Graphic Designer II
- Revelyst (Irvine, CA)