- Abbott (San Diego, CA)
- … compliance. + Collaborate closely with cross-functional teams including Regulatory Affairs , Quality Assurance, Biostatistics, and Program Management. ... in-vitro diagnostics for 510(k) OTC and dual 510(k) and CLIA waiver regulatory pathways. They will work closely with cross-functional teams and participating on… more
- BeOne Medicines (Emeryville, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input on global study… more
- University of Miami (Miami, FL)
- …the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as ... This role is also responsible for the independent execution of regulatory -related decisions/strategies and coordinates work with study managers and other relevant… more
- Danaher Corporation (New Brighton, MN)
- …to the Sr. Manager, Quality Engineering and is part of the Quality Assurance and Regulatory Affairs team located in New Brighton, Minnesota and will be an ... on-site role. In this role, you will have the opportunity to: + Lead value stream specific quality tasks, including change control, training, non-conformance, and CAPA closure. + Conduct quality data analysis, trending, root cause investigation, and… more
- The Coca-Cola Company (Atlanta, GA)
- …with cross-functional teams, including Global Category Innovation, Scientific & Regulatory Affairs , Technical Consumer Research and external partners, ... interpret relevant scientific literature and studies, ensuring research outputs meet regulatory , safety, and quality compliance standards. + Foster an innovation… more
- Abbott (Maple Grove, MN)
- …+ Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs , Library Services, Product Performance Group (PPG), Quality ... Clinical Evaluation** . The Sr. Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing...Engineering, Clinical Affairs , Clinical Science, Risk Management and Medical … more
- Novolex (Lake Forest, IL)
- …against budget. Provide monthly pricing as needed to manufacturing sites. 7. Work with Regulatory Affairs team and suppliers to ensure 100% regulatory ... compliance 8. Facilitate meetings to drive cost savings initiatives. This means demonstrating the ability to develop agendas, lead meetings, and document & publish critical results **Skills and Competencies:** 1. Demonstrated ability to comfortably and… more
- Medtronic (North Haven, CT)
- …assessments, develop, and execute remediation plans + Support quality audits and regulatory affairs technical file submissions + Author technical deficiency ... across global locations to ensure long term manufacturing efficiency, quality, and regulatory compliance. At Medtronic, we bring bold ideas forward with speed and… more
- CVS Health (Woonsocket, RI)
- …with stakeholders by partnering closely with Field Leadership, Store Operations, Legal, Regulatory Affairs , Business Compliance Office, and IT to ensure ... appropriate levels of support and collaboration + Work cross-functionally with CSC partners to develop strategies and action plans to mitigate identified risks and opportunities **Required Qualifications** + **5-7 years** of Prior Relevant Work Experience +… more
- University of Miami (Miami, FL)
- …knowledge of Good Clinical Practice Guidelines, IRB review, reporting requirements and regulatory affairs . + Oversees schedule and follows-up on progress in ... the development of the consent forms. + Communicates with internal and/or external regulatory oversight entities (eg IRB, NIH). + Participates in the development of… more