- Abbott (Sylmar, CA)
- …CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific , regulatory and business issues ... solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac...preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related area. Note:… more
- Edwards Lifesciences (Irvine, CA)
- …are at the heart of everything we do. As the Senior Director, THV Medical Affairs , you will drive strategy development, evidence generation initiatives, and ... health economics and outcomes research teams ensuring seamless integration of medical affairs initiatives into broader organizational efforts. + Building… more
- Edwards Lifesciences (Irvine, CA)
- Patients are 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 ... patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us...grant recipients. + Collaborate Across Teams: Work closely with Medical Affairs , Legal, and Finance teams to… more
- Terumo Neuro (Aliso Viejo, CA)
- **12814BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval submission ... representative from Regulatory to ensure regulatory compliance. + Depending on product/ project complexity, develop or assist in developing regulatory strategy for… more
- Kelly Services (Irvine, CA)
- …SMEs to implement the best enterprise business solutions/propositions + Guide Medical Affairs SMEs through the development of project plans and task tracking ... + The Project Manager will work with Medical Business Partners; R&D, Clinical Affairs , Regulatory...Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts… 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 ... products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity...field with 4 years of related experience working in medical affairs , clinical affairs and/or… more
- J&J Family of Companies (Irvine, CA)
- …to pilot to full production + Works with cross-functional team including, quality, medical affairs , regulatory, manufacturing, teams toward completion of all ... Development **Job Sub** **Function:** R&D Mechanical Engineering **Job Category:** Scientific /Technology **All Job Posting Locations:** Irvine, California, United States… more
- Edwards Lifesciences (Irvine, CA)
- Patients are 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 ... evaluation and clinical study reports + Prepare moderately complex medical writing documents/deliverables for assigned project (s) +...related field with 3 years of experience working in medical writing, medical affairs , clinical… more
- J&J Family of Companies (Irvine, CA)
- …congresses + Collaborate closely with internal cross-functional teams (Clinical, Biostatistics, Medical Affairs , Global Strategic Marketing, Health Economics and ... seeking a **Staff Clinical Research Scientist** to support the scientific publication medical writing needs of the...+ Excellent written and oral communication skills + Strong project management skills to balance multiple projects + Excellent… more
- J&J Family of Companies (Irvine, CA)
- …as needed + Develops positive relationships with diverse cross-functional teams including Medical Affairs , Health Economics and Market Access, Global Strategic ... scientific communications and evidence dissemination plans in a medical device or related industry, is versed in supervising...PharmD _strongly preferred_ . + 10-12 years of clinical, medical affairs or related technical experience (8-10… more
- Grifols Shared Services North America, Inc (Orange County, CA)
- …compliant medical device quality system for R&D and informing project teams of needed updates/changes **Additional responsibilities:** + Represent R&D Compliance ... of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing… more
- AbbVie (Irvine, CA)
- …solicit consultant or opinion leader input related to the indication(s); partner with Medical Affairs , Commercial, and other functions in these activities as ... development programs supporting the overall product development plan based on strong medical and scientific principles, knowledge of compliance and regulatory… more
- J&J Family of Companies (Irvine, CA)
- …as needed + Develops positive relationship with diverse cross-functional teams including Medical Affairs , Health Economics and Market Access, Global Strategic ... + A minimum of a Master's Degree with at least 10 years of clinical, medical affairs or related technical experience. + PhD/MD/ PharmD with at least 8… more
- AbbVie (Irvine, CA)
- …Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...or those of a team. Lead/develop statistical strategy for project development and regulatory submission. + Provide statistical leadership… more
- Terumo Neuro (Aliso Viejo, CA)
- …as well as reports of committee findings and results. + Partner with clinical research project managers and Medical Affairs and Safety Manager to ensure ... regular progress updates. + Support clinical science and regulatory affairs functions by utilizing medical expertise to...and other scientific documentation. + Support clinical project management function by utilizing medical expertise… more
- Grifols Shared Services North America, Inc (Orange County, CA)
- …Regulatory Affairs and other functions + Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract ... + Serve as a key part of the cross-functional project team, supporting the overall strategy, budget, and timeline...scientific meetings and presentations + Attend and provide medical support for investigator and consultant meetings and clinical… more
- Edwards Lifesciences (Irvine, CA)
- …journey. Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and ... patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us...with robust knowledge on design control requirements. + Develop project plans to assess technology and drive project… more
- Actalent (Irvine, CA)
- …(Master's preferred). + 8-10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry. + Familiarity with global ... in ensuring the integrity and compliance of marketing claims associated with our medical devices. The ideal candidate will have a strong background in quality… more
- Edwards Lifesciences (Irvine, CA)
- …journey. Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and ... patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us...with team members and cross-functional teams (eg, Marketing, Clinical Affairs , Regulatory Affairs ) + Develop training tools… more
- Terumo Neuro (Aliso Viejo, CA)
- …is on both theoretical and practical solution development through the application of the scientific process and project management. Job duties: + Manage a group ... with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues. +… more