- 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 ... and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the… more
- Abbott (Westford, MA)
- …and other regulatory requirements + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... operating procedures, processes, and task assignments. Maintains positive and cooperative communications an collaboration with all levels of employees, customers, contractors, and vendors + Performs other related duties and responsibilities, on occasion, as… 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
- System One (Harvard, MA)
- …making of non-conformance through a deep understanding of Quality Systems Regulatory expectations + Reviews and approves Quality, Quality Control, Validation and ... as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements. + Ability to coach… 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
- AbbVie (Worcester, MA)
- …SCADA, and Data Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions ... for Day-to-day operational shift support for Upstream and Downstream Drug Substance manufacturing. + Oversee troubleshooting, upgrades and lifecycle planning… more
- Rhythm Pharmaceuticals (Boston, MA)
- …of Drug Safety and Pharmacovigilance experience. + Knowledge of FDA , ICH, EU Regulations and Requirements for Pharmacovigilance required. + Solid understanding ... of cross-functional drug development processes ( Regulatory , Clinical Operations, Data Management, and Biostatistics). + Demonstrable organizational and workflow… more
- Abbott (Boston, MA)
- …scheduling appointments, and making travel plans. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company ... policies, operating procedures, processes, and task assignments. + Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. + Interacts with customers and assigned institutions,… 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 ... all other applicable laws, regulations, and standards. **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill,… more