- Sumitomo Pharma (Boston, MA)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the US. He/She...provides possible solutions and mitigation strategy + Ensures the quality and content of all submissions to Health Authorities… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... be critical in helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with other key functional… more
- Takeda Pharmaceuticals (Lexington, MA)
- …global organization, fostering talent, accountability, and high performance to advance quality , ensure regulatory readiness, and drive innovation and operational ... Device Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC), where applicable. + Lead and develop a high-performing,… more
- Integra LifeSciences (Braintree, MA)
- …written and verbal communication skills, with proven ability to draft and review regulatory and quality system documentation. + Familiarity with quality ... set new standards of care. **SUMMARY DESCRIPTION** The Associate Manager, Quality Compliance supports the development, maintenance, and continuous improvement of the… more
- Hologic (Marlborough, MA)
- …continuous improvement. **Behaviors:** + Strategic thinker, with a focus on aligning quality objectives to organizational goals and regulatory requirements. + ... Sr Manager, Quality Assurance Newark, DE, United States Marlborough, MA,...mentor a high-performing team, and ensure adherence to global regulatory standards. If you're ready to make a meaningful… more
- Catalent Pharma Solutions (Chelsea, MA)
- …establish and maintain comprehensive systems that establish, document and monitor Quality standards and requirements that meet Catalent, Regulatory and ... Quality and Compliance standards and requirements, with preferable FDA experience; + Demonstrated knowledge of Change management and... Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, IBM, FDA ,… more
- Astrix Technology (Devens, MA)
- …Program + Conduct internal and supplier audits to ensure compliance with ISO and FDA Quality System Regulation (QSR) standards. + Collect, review, and interpret ... preferred. + 3-5 years of relevant experience in a quality , regulatory , or laboratory environment. + Strong...or laboratory environment. + Strong knowledge of ISO and FDA Quality System Regulations (QSR). + Proficiency… more
- Philips (Cambridge, MA)
- …right fit if:** + You have a minimum of 10+ years' experience in Design Quality Engineering /Risk management for FDA regulated Medical Device (21 CFR 820, ISO ... effectively. + You have a minimum of a Bachelor's Degree (Required) in Engineering, Quality , Regulatory or comparable disciplines. + You must be able to… more
- Integra LifeSciences (Braintree, MA)
- …and manage time to meet organizational goals and objectives. + Experience with External Regulatory Agency audits (ie, Notified Bodies and FDA ). + Knowledge of ... pathways to advance patient outcomes and set new standards of care. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for the efficient… more
- Integra LifeSciences (Braintree, MA)
- …A minimum of 2-4 years' experience in a medical device, pharmaceuticals, Quality / Regulatory Compliance, or other cGMP regulated product preferred environment. + ... and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. +...Familiarity with application of FDA and/or ISO quality standards in a… more