- Fujifilm (Boston, MA)
- …+ Comply with all applicable S. Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... consistent across all zones. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... factors, which may include customer impact, HCUS business priorities, and regulatory requirements. Normally receives little instruction on day-to-day work and… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... level of customer satisfaction + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties inherent… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …of global transparency, FMV, and reporting requirements + Strong knowledge of global regulatory and compliance standards ( FDA , EFPIA, IFPMA, PhRMA) + Proven ... with clinical, medical, and commercial partners + Strong understanding of regulatory , compliance, and ethical standards governing HCP interactions globally +… more
- Parexel (Boston, MA)
- …when applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, ... to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …formulation development for synthetic molecules, biologics, cell therapies, and other drug modalities. + Provide statistical support and leadership for Takeda ... and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs, and Global Quality to explore methods and implement CMC… more
- Teleflex (Mansfield, MA)
- …and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, ... resolve them. * Ensure Compliance: Adhere to all safety, regulatory , and quality standards in all tasks. * Additional...the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired *… more
- Takeda Pharmaceuticals (Boston, MA)
- …products (MES, ERP,MODA, LIMS). Knowledge management product (PLM, R&D Search). Drug and Device Management Lab Validation. + Structure and resource product ... with global regulations (eg, GxP, 21 CFR Part 11, FDA ) and Takeda's quality and risk management standards. +...in strategic governance forums, investment planning committees, and external regulatory or industry working groups as needed. + Ensures… more