- Fujifilm (Albany, NY)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... into actionable user stories and system requirements. + Integrate input from regulatory , marketing, and implementation teams to maintain compliance and accuracy in… more
- Pfizer (New York, NY)
- …solutions into business workflows, ensuring alignment with standardized processes, regulatory requirements, and enterprise architecture principles. + Develop and ... that fully comply with Industry regulations and quality standards ( FDA , GxP). + 5+ years of experience leading the...medical leave, and health benefits to include medical, prescription drug , dental and vision coverage. Learn more at Pfizer… more
- Fujifilm (Albany, NY)
- …+ 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 (Albany, NY)
- …+ 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 (Albany, NY)
- …+ 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
- Fujifilm (Albany, NY)
- …+ 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
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …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 (Albany, NY)
- …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
- Corning Incorporated (Oneonta, NY)
- …Create technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO Standards. + Serve as a ... approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …stage in the asset lifecycle, benefit risk assessment, safety responses to regulatory agency queries, safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) ... PV and/or relevant medical field or equivalent in lieu industry experience in drug safety including significant experience with PSURs/ DSURs/(d) RMPS; or in clinical… more