- Fujifilm (Boston, MA)
- …of the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more
- Sanofi Group (Cambridge, MA)
- …the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions ... development strategies for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project… more
- Integra LifeSciences (Braintree, MA)
- …to resolve environmental control issues. + Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of ... management systems (BMS) and automated environmental controls. + Knowledge of regulatory requirements in the medical device or pharmaceutical industry. + Experience… more
- AbbVie (Worcester, MA)
- …SCADA, and Data Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions ... rules, and regulations. + Collaborate with cross-functional teams including Operations, Quality , IT and Maintenance. + Manage and supports control system including… more
- Teleflex (Chelmsford, MA)
- …for processsing changes. * Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures ... driven by our purpose to improve the health and quality of people's lives. Through our vision to become...totally Customer Centric in our unrelenting focus on Improving Quality , Service and Value as perceived by our customers.… more
- ThermoFisher Scientific (Agawam, MA)
- …distribution center, coaching an operations manager and supervisors in providing high quality services to the facility's customer base. This will be accomplished ... initiatives, fostering employee engagement, and maintaining a safe, efficient, and high- quality operating environment. **A Day in the Life** + Responsible for… more
- Dana-Farber Cancer Institute (Methuen, MA)
- …performed by other employees. + Ability to maintain compliance with all regulatory agency (eg Joint Commission (formerly JCAHO),CAP, FDA , AABB) requirements. ... Laboratory Technician is responsible for adherence to the laboratory quality control policies and procedures to ensure reporting of...and verify test results. + Adhere to the laboratory quality control policies, documents all quality control… more
- Charles River Laboratories (Wilmington, MA)
- …of client studies or procedures. + Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements. + ... leader in the production and distribution of the highest quality research animal, with 1 out of 2 animal...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Medtronic (Newton, MA)
- …and debugging software that interfaces with hardware components. Experience with regulatory compliance and security protocols specific to medical software (eg, ... HIPAA, FDA regulations) is preferred but not required. The ideal...with cross-functional teams, including hardware engineers, product managers, and quality assurance, to define software requirements and deliver high-… 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 or post go-live support cases in compliance with the company's quality procedures. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a… more