- Abbott (Sylmar, CA)
- …of device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm ... Management team in Sylmar CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, … more
- Abbott (Sylmar, CA)
- …fingersticks. Our location in **SYLMAR, CA** currently has an onsite opportunity for a Manager of Regulatory Affairs in the Cardiac Rhythm Management ... The Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. Knowledge… more
- Fortive Corporation (Irvine, CA)
- The Medical & Scientific Affairs Project & Operations Manager will work under the supervision of the Chief Medical & Scientific Officer (CMO). This role ... and guidelines, this position: + The Medical & Scientific Affairs (MA) Project & Operations manager...response letters, etc. + Collaborate with various departments, including regulatory affairs , QA and product SMEs to… more
- Medtronic (Irvine, CA)
- …innovation in a more connected, compassionate world. **A Day in the Life** The Sr Regulatory Affairs Specialist will play a key role in sustaining the current ... regulatory requirements and partners with the international regulatory affairs group to support regulatory...regulatory agencies and Notified Body and serve as regulatory liaison on the project team throughout… 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 ... and guidance; assess impact of such regulations and guidance on assigned project (s), propose suggestions on utilizing regulatory updates to expedite approval… more
- Envista Holdings Corporation (Brea, CA)
- …claims and literature. + Prepares monthly reports on status of current issues to the Manager of Regulatory Affairs . + Assists with Customs requests. + ... **Job Description:** The ** Regulatory Affairs Specialist** is responsible for... Management. + Any duties or projects assigned by Manager . **REQUIREMENTS:** + Bachelor's Degree (BA/BS) from four-year college/university… more
- Edwards Lifesciences (Irvine, CA)
- …Driving strategic initiatives as a key facilitator, thought leader, and internal project manager . + Executing societal sponsorship engagements through strong ... at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based… more
- Grifols Shared Services North America, Inc (Orange County, CA)
- …8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or ... Hiring Ordinance.** Learn more about Grifols (https://www.grifols.com/en/what-we-do) **Req ID:** 527460 **Type:** Regular Full-Time **Job Category:** Regulatory Affairs… more
- AbbVie (Irvine, CA)
- …In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs , the appropriate regulatory strategies for ... Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs , Research and Development. Additional Information AbbVie is… more
- Terumo Neuro (Aliso Viejo, CA)
- …with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues. + Manage ... **12788BR** **Title:** Manager , Engineering R&D **Job Description:** Manage individuals from...development through the application of the scientific process and project management. Job duties: + Manage a group of… more
- Edwards Lifesciences (Irvine, CA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Edwards Lifesciences (Irvine, CA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… 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.). ... Aesthetics | An AbbVie Company Job Description The Marketing Operations, Senior Manager works cross-functionally to project manage the review process for… more
- Edwards Lifesciences (Irvine, CA)
- ** Manager , Clinical Marketing TMTT** Innovation starts from the heart. Heart valve disease and critical care therapies impact millions of lives, spanning all ages ... of patients suffering from the effects of valvular heart disease. The Manager - Clinical Marketing, TMTT, is responsible for leading patient-focused innovation by:… more
- AbbVie (Irvine, CA)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. ... Oversee project -related training of investigators, study site personnel, and AbbVie...scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. Experience… more
- AbbVie (Irvine, CA)
- …strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. ... Oversee project -related training of investigators, study site personnel, and AbbVie...scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. Lead… more
- Edwards Lifesciences (Irvine, CA)
- …strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs , Supplier Development Engineering and Receiving Inspection. ... closure. + Report on supplier part qualification status at recurring cross-functional project meetings + Collect and analyze Quality metrics relating to Supplier… more