- AbbVie (Irvine, CA)
- …https://global.allerganaesthetics.com/. Follow Allergan Aesthetics on LinkedIn. Job Description Description The Manager Regulatory Affairs represents US ... a scientific field, plus 2 years' experience in regulatory affairs . + Experience in US medical devices regulatory affairs is necessary. +… 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. Working...us and be part of our inspiring journey. The Manager , Medical Writing will provide guidance, develop, and… more
- J&J Family of Companies (Irvine, CA)
- Manager , Regulatory Affairs - Biosense Webster,...of relevant experience with at least five 5 years in Regulatory Affairs of Medical Devices. * ... & Johnson MedTech family, is currently recruiting for a ** Manager , Regulatory Affairs ** . _This...IDE/510K/ and PMA submissions for class II and III medical devices for commercialization in the USA. * Develop… more
- Medtronic (Northridge, CA)
- …more than 160 countries. **A Day in the Life** As Principal Regulatory Affairs Specialist, you will develop and implement medical device regulatory ... from worldwide regulatory bodies. Working with global Regulatory Affairs colleagues, you will ensure submissions...level. All significant issues will be reviewed with the manager . + Maintain proficiency in global regulatory … more
- Medtronic (Northridge, CA)
- …partners of sustaining changes through the Medtronic Agile system. Reporting to the Regulatory Affairs Manager , you will collaborate with various ... Change Lives** In this dynamic role as a Senior Regulatory Affairs Specialist, you will be responsible...highly skilled, flexible, extremely efficient, versatile and agile in medical device product development for the benefit of our… more
- Veterans Affairs, Veterans Health Administration (Long Beach, CA)
- …and acquisition, and management of regulatory affairs and compliance. Responsibilities Total-Rewards-of-an-Allied-Health-VA-Career-Brochure.pdf Medical ... within the Pathology and Laboratory Medicine Service. The Laboratory Manager shares, with the Director/ Medical Director of...at the local, network and national program offices. Manage regulatory affairs and compliance. Keep abreast of… more
- AbbVie (Irvine, CA)
- …You To Know The Associate Director / Director, Global Body Contouring, Global Aesthetics Medical Affairs (GAMA) is a key strategic leader in the GAMA ... to device and pharmaceutical approvals. + Progressive experience in healthcare industry and medical device industry in medical affairs function. + Minimum… more
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Description The Sr Manager Regulatory Affairs represents US regulatory ... a scientific field, plus 4 years' experience in regulatory affairs . + Experience in US medical devices regulatory affairs is necessary. +… more
- Edwards Lifesciences (Irvine, CA)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... , Clinical Portfolio Management (the formal Edwards title is Manager , Clinical Affairs ) will manage the global...for (Preferred)** : + Relevant clinical trial experience in medical device, biotech or pharma industry + Cardiology related… more
- AbbVie (Irvine, CA)
- …potential issues are resolved for overall achievement of deadlines (Proofing requirements, Regulatory Affairs return of jobs, 2253 submission to OPDP, etc.). ... review process and is responsible for ensuring the process efficiency involving Medical , Legal, Regulatory , and Compliance teams, while conforming with company… more
- Envista Holdings Corporation (Orange, CA)
- … regulatory compliance, scheduling, and cost objectives. + Collaborate with Regulatory Affairs on 510(k) submissions, product licensing, and regulatory ... **Job Description:** The **Implant Direct** **Project Manager ** plays a key role in leading the...highly desired. + 3+ years project management experience in medical device or a similar regulated industry + Proficient… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …functionally with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues. ... product development and project management of mobile application software for medical devices. **External-Facing Title:** Engineering Manager , R&D **Posting… more
- Edwards Lifesciences (Irvine, CA)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion...be part of our inspiring journey. As the **Senior Manager , Clinical Contracts (Vendors & Suppliers)** for our THV… 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,...related topics. Documents each meeting. Meets with the Center Manager and Compliance Specialist (or designees) during weekly visits… more
- J&J Family of Companies (Irvine, CA)
- …He/she also partners with leaders in multiple departments including R&D, Clinical Sciences, Medical Affairs , Regulatory Affairs , and Global Strategic ... insight, advice, and support to other groups in Clinical Affairs and R&D on study design and execution (10%)....minimum of 5 years' experience as a clinical operations manager . * Broad understanding of medical devices/instrumentation… more
- AbbVie (Irvine, CA)
- …Clinical Development experts + Statistical Programmers + Data Science experts + Global Medical Affairs experts + Regulatory experts Additional Information ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients. +… more
- Edwards Lifesciences (Irvine, CA)
- …products and therapies + Interface with R&D, manufacturing, clinical development, clinical affairs , quality and regulatory personnel to ensure compliance with ... journey. This is an exceptional opportunity for an experienced medical device engineer with technical expertise to contribute to...reduce conservatism + Be an SME in communication with regulatory bodies + Mentor other engineers and technicians +… more
- Medtronic (Northridge, CA)
- …to increase product adoption + Work closely with internal functions like Governmental Affairs , Clinical, Regulatory , Quality and our commercial teams as well as ... and reimbursement-related advice to product development teams, marketing, sales, regulatory , clinical, and business leaders. This includes ensuring payor… more
- Food and Drug Administration (Irvine, CA)
- …(FDA), Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), Office of Medical Products and Specialty Laboratory Operations ... GS-0403 series, Microbiologist: A degree: microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and… more
- The Cigna Group (Anaheim, CA)
- …interface with matrix partners for network implementation and maintenance. + Partner with Regulatory Affairs to ensure all network filings are timely and ... with matrix partners including but not limited to, Claims Operations, Medical Management. Credentialing, Legal, Medical Economics, Compliance, Sales and… more