- Kedplasma (Slidell, LA)
- …within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. Additionally, responsible for providing independent medical judgment and ... Supports optimum delivery of services as an ethical and high- quality provider of plasma. Upholds KEDRION values while leading...Review as required. + Complies with all facility SOPs, FDA and EU regulations, OSHA, PPTA, CLIA and COLA… more
- Insight Global (Rochester, MN)
- …is seeking a contracted Regulatory Specialist to support the Vice President of Quality Assurance and Regulatory Affairs. The contractor will focus on the execution ... of regulatory documentation, submissions, and compliance tasks to ensure timely delivery of project milestones....hands-on experience in EU MDR and working knowledge of FDA , Health Canada, and Japan PMDA requirements. Scope of… more
- Candela Corporation (Marlborough, MA)
- …Reliability and maintainability trends . Operate Sustaining Engineering activities in an FDA regulated environment that meets internal quality requirements and ... team interfacing with Marketing (GBU), Clinical, Service, Manufacturing, Regulatory, and Quality organizations when needed . **Essential Job Functions** . Manage a… more
- Fresenius Medical Center (Waltham, MA)
- …+ Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory bodies, to maintain market access and product ... with business objectives and drive the timely delivery of high- quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + **Regulatory Strategy… more
- Abbott (Minnetonka, MN)
- …based on the business goals and aligned with Lean Manufacturing principles and in compliance to FDA and all other applicable agency regulations + Develop the ... or department within the organization. Responsibility for improvements in safety, quality , on-time delivery, cost and employee development are key deliverables.… more
- Community Health Systems (Bluffton, IN)
- … compliance with state, federal, and regulatory standards, including FDA /MQSA and ACR requirements. **Essential Functions** + Performs mammography imaging ... and staff safety. + Ensures equipment functionality and maintenance, performing routine quality control testing per ACR and FDA /MQSA requirements. + Reviews… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …standpoint, identify and respond to signal analysis, and submit to regulatory agency ( FDA /Health Canada) within timelines to achieve 100% compliance with US ... norm + Anchor drug safety regulatory inspection in US ( FDA regulatory agencies),participate in audits and provide support in...to be documented and set up. Establish the pharmacovigilance Quality Management System and achieve compliance with… more
- Terumo Neuro (Aliso Viejo, CA)
- …met and consistent. + Audit data management vendors, as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and ... and developing and/or enhancing data management processes to ensure complete, accurate, high quality clinical data and adhering to Good Clinical Practices and FDA… more
- Abbott (Plymouth, MN)
- …or modified, are distributed to appropriate personnel. + Reviews device labeling for compliance with FDA submissions and applicable regulations. + Supports the ... and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory agencies. + Acts as liaison between the Company and… more
- Lilly (Indianapolis, IN)
- …Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization. ** Compliance & Documentation** : + ... visual inspection program and processes to ensure the highest quality standards. The ideal candidate will provide expert guidance...Ensure compliance with FDA and any other global applicable regulatory standards by… more