- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …approaches. + Ensure training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance & Risk Management** + ... cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver… more
- Carrier (Beverly, MA)
- …Regulatory Intelligence & Monitoring** + Interpret and monitor global regulatory requirements (eg, CE/MDR, FDA , ISO standards, environmental/transport ... Affairs Certification (RAC) or equivalent professional certification + Regulatory Knowledge on US: FDA , FCC; EU:...professional certification + Regulatory Knowledge on US: FDA , FCC; EU: MDR, Radio Equipment Directive, Low Voltage,… more
- Abbott (Springfield, MA)
- … requirements. * Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... to customers. * Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends. * Resolves and/or facilitates… more
- J&J Family of Companies (Danvers, MA)
- …sales, and education. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... investigators as defined by study-specific requirements and by the applicable regulatory code. + Maintain open communication and relationships with key site… more
- Bristol Myers Squibb (Devens, MA)
- …and EU cGMP regulations and guidance. + Knowledge and proven experience in FDA , EMA, or other regulatory authority. + Demonstrated leadership, interpersonal, ... and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products + Directly… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... 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 (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... 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 (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Integration, Customer Service, etc.). + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the… more
- Fujifilm (Boston, MA)
- …systems. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... 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)
- …others. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... into actionable user stories and system requirements. + Integrate input from regulatory , marketing, and implementation teams to maintain compliance and accuracy in… more