- 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 ... domestic and international regulatory environments. Working in...Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices +… 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 ... international regulatory environments....Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices strongly… 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 ... domestic and international regulatory environments. Working in...Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices +… 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 ... domestic and international regulatory environments. Working in...Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices +… more
- Edwards Lifesciences (Irvine, CA)
- …as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach. BD is one of ... the largest global medical technology companies in the world and is advancing...bd.com **How you'll make an impact:** + Represent the regulatory function on manufacturing and product development teams to… more
- Edwards Lifesciences (Irvine, CA)
- …Bachelor's Degree in a related field with 6 years of related experience working in medical affairs , clinical affairs and/or clinical science; OR + Master's ... in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory ...field with 4 years of related experience working in medical affairs , clinical affairs and/or… 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 ... international regulatory environments....portfolio of products across Surgical business unit. The Sr. Specialist will be an experienced medical device… 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 ... and post market root cause analysis, and responses to regulatory inquiries. Responsible for continuous improvement activities and problem-solving...and five (5) years of experience as a Consumer Affairs Specialist , Medical Device Reporting… more
- Edwards Lifesciences (Irvine, CA)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols +… more
- Edwards Lifesciences (Irvine, CA)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... **What else we look for (Preferred):** + Experience in clinical trials or regulatory compliance + Good understanding of global medical device regulations,… more
- Edwards Lifesciences (Irvine, CA)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... Knowledge and understanding of cardiovascular science + Moderate understanding of medical device regulatory requirements and documents, device accountability and… 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...teams. Qualifications: + Preferably 3+ years' experience in the Medical Device / Pharmaceutical industry or medical … more
- CSL Plasma (Anaheim, CA)
- …for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides training to ... **Job Description Summary** Provides medical oversight to Medical Staff Associates,...each meeting. Meets with the Center Manager and Compliance Specialist (or designees) during weekly visits to the center.… more
- Actalent (Irvine, CA)
- …interaction with various departments such as Advanced Operations, Product Development, Regulatory Affairs , and Marketing, fostering a collaborative and ... SpecialistJob Description We are seeking a dedicated Quality Management Systems (QMS) Specialist who will play a crucial role in ensuring compliance with internal… more
- City National Bank (Irvine, CA)
- …and closes loan transactions, ensures conformance with Bank policy and regulatory requirements. Exercises sound credit and risk judgment in approving transactions. ... the Bank by actively participating in outside civic and community affairs , business and industry-related organizations, and other professional activities as… more
- Antech Diagnostics (Fountain Valley, CA)
- …and Abilities** + Broad experience in Animal and/or Human Health commercial operations, Regulatory Affairs , and R&D + Experience in developing and validating ... and technology; veterinary professional education and training; and board-certified specialist support services. _Antech offers an industry competitive benefits… more
- City National Bank (Irvine, CA)
- …and closes loan transactions, ensures conformance with Bank policy and regulatory requirements. Exercises sound credit and risk judgement in approving transactions. ... the Bank by actively participating in outside civic and community affairs , business and industry-related organizations, and other professional activities as… more