- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... medical or sincerely held religious belief or other legally required exemption._ _In compliance with the ADA Amendments Act, should you have a disability that… more
- BioLife Plasma Services (Boston, MA)
- …develop the skills to meet production and cost goals while ensuring compliance with regulations and BioLife SOPs. + **Travel Opportunities:** Through our ... QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, ... operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles and CPV.… more
- Children's Hospital Boston (Boston, MA)
- …to ingredients and equipment, and preparation skill levels. + Ensures compliance with departmental quality initiatives, as well as regulatory and accreditation ... standards (Joint Commission, DPH, FDA , CMS). + Maintains professional skills and knowledge through educational programming, conference attendance, and leadership in… more
- Takeda Pharmaceuticals (Boston, MA)
- …programs. + Independent execution and interpretation of experiments in compliance with appropriate global regulatory guidance. + Effective and independent ... global regulatory guidelines, expectations and corresponding industry best practices (eg, FDA guidelines, Good Laboratory Practices (GLP)) + Experience in managing… more
- Boston University (Boston, MA)
- …of IRB-approved research studies to ensure that research is conducted in compliance with applicable regulations, policies, and guidance. These include both for-cause ... + Expert understanding of policies and regulations guiding human research, including FDA , OHRP, ICH GCP, applicable NIH policies, etc. - Excellent writing skills… more
- Takeda Pharmaceuticals (Boston, MA)
- …of global cross-functional teams which require experienced interpretation of applicable EMA/ FDA /ICH/WHO/Global regulations to ensure CMC compliance within the ... organization. + Support submission team members to define CMC content (data and documentation) requirements for regulatory submissions and reviews the content for conformance with established requirements. + Support and/or contribute to business process… more
- Philips (Cambridge, MA)
- …for hardware and Software design and ensure they meet quality and compliance standards for every planned milestone. Validates key design inputs like usability, ... a minimum of 3+ years' experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design… more
- Beth Israel Lahey Health (Boston, MA)
- …operations. 4. Ensures appropriate staffing of pathology laboratories in compliance with institutional and regulatory standards. Ensures appropriate hiring, training ... state and organizational regulatory guidelines and uphold requirements for CAP, JC, FDA , AABB, FACT and others. Work collaboratively with hospital quality and… more
- Sanofi Group (Cambridge, MA)
- …regional /country regulatory teams to address labeling implementation or compliance issues. + Monitor external regulatory environment, competitor labeling trends, ... You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling best practices. + Strategic thinking… more