- Sanofi Group (Cambridge, MA)
- …and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion ... promotion, disease-state, market access, and press materials. Submits materials on form FDA 2253 when applicable. + Provides US RA AdPromo strategic guidance and… more
- Philips (Cambridge, MA)
- …and EU MDR Tech Files required. + Your skills include knowledge of quality system requirements and FDA and/or International product approval process, demonstrate ... updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general… 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
- North Coast Seafoods (New Bedford, MA)
- …and maintenance work. + Safety & Compliance : Enforce safety regulations and compliance with OSHA, FDA , USDA, and GMP standards in a seafood manufacturing ... of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer… more
- Bristol Myers Squibb (Devens, MA)
- …Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality , and compliance environments. Prefer to also have knowledge of GMP ... Cell Therapy team. The **Manager, Shop Floor QA** is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to… more
- Cognizant (Boston, MA)
- …. Continuously review and refine testing processes, contributing to improved productivity, quality , and compliance with digital initiatives. . Act as the ... opportunity for you! **About Cognizant's QEA Practice:** We are the largest Quality Assurance Practice Globally servicing 800+ Clients. We bring the industry leading… more
- Sanofi Group (Cambridge, MA)
- …efficient prioritization of multiple requests, delegation as needed, and delivering high- quality service to business partners. Confidence working with senior leaders ... counsel concerning a broad range of legal issues, including, interpretation of FDA and other regulations, including the False Claims Act, Anti-Kickback Statute and… more
- Integra LifeSciences (Braintree, MA)
- …standards, KPIs and procedures. + Support the implementation of new or improved quality control systems as needed. + Ensure compliance with industry regulations, ... years GMP/GLP laboratory experience in a medical device, pharmaceuticals, Quality /Regulatory Compliance , or other regulated industry +...or other regulated industry + Familiarity with application of FDA and/or ISO quality standards in a… more
- Fujifilm (Boston, MA)
- …vendor agreements, non-disclosure agreements, development, manufacturing and service agreements, quality agreements and clinical trial and research agreements, among ... legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma...Experience in legal matters involving tariffs and other trade compliance issues would be a plus. + Strong contract… more
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