- Envista Holdings Corporation (Brea, CA)
- **Job Description:** The ** Regulatory Affairs Specialist ** is responsible for assembling CE Technical files and final review of deliverables for MDR ... regulatory compliance with the goal of achieving...+ Performs special projects at the direction of the Regulatory Affairs Management. + Responsible for assembling… more
- Terumo Neuro (Aliso Viejo, CA)
- **12814BR** **Title:** Sr. Specialist , Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval submission ... 6. Ability to comprehend technical documents and concepts. **External-Facing Title:** Sr Specialist , Regulatory Affairs **Posting Country:** US - United… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Provide… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... labeling content, product and process changes, and product documentation to assure regulatory requirements compliance , consistency, and accuracy **What you will… more
- Edwards Lifesciences (Irvine, CA)
- …procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Provide ... content product and process changes, and product documentation to assure regulatory requirements compliance , consistency, and accuracy + Other incidental… more
- Medtronic (Northridge, CA)
- …Technical Studies or related field and two (2) years of experience as a Consumer Affairs Specialist , Medical Device Reporting Compliance Specialist or ... Technical Studies or related field and five (5) years of experience as a Consumer Affairs Specialist , Medical Device Reporting Compliance Specialist or… more
- Edwards Lifesciences (Irvine, CA)
- …available products in collaboration with cross functional teams (eg, Marketing, Clinical Affairs , Regulatory Affairs , Legal) + Responsible for successful ... of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to...aspects of clinical therapeutic areas + Substantial knowledge of regulatory , compliance , and AdvaMed requirements + Strict… more
- Edwards Lifesciences (Irvine, CA)
- …**What else we look for (Preferred):** + Experience in clinical trials or regulatory compliance + Good understanding of global medical device regulations, ... activities and training curriculum for each role in the global THV Clinical Affairs function. Analyze training data, evaluate compliance reports and complete… more
- Fortive Corporation (Irvine, CA)
- …+ Work together with engineering, project management, manufacturing, quality, planning, marketing, regulatory affairs , and suppliers to identify and drive total ... The Strategic Sourcing Specialist will have direct responsibility for supplier relationship...& Past due), quality (DPPM), lead-time, DPO, innovation, and compliance and audit needs in a highly regulated environment.… more
- Actalent (Irvine, CA)
- …interaction with various departments such as Advanced Operations, Product Development, Regulatory Affairs , and Marketing, fostering a collaborative and ... Document Control Specialist - QMS ** For Immediate consideration please... who will play a crucial role in ensuring compliance with internal and external regulatory requirements.… more
- CSL Plasma (Anaheim, CA)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... related topics. Documents each meeting. Meets with the Center Manager and Compliance Specialist (or designees) during weekly visits to the center. Serves as a… more