- Beth Israel Lahey Health (Boston, MA)
- …Assist investigators and study teams in preparing and submitting IND applications to the FDA . Preparation and submission of annual reports to the FDA . Submission ... submission and activation of single patient IND protocols to the FDA and IRB. Interact with the FDA on emergency use of a test article without IRB review… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate ... regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, maintains and organizes Regulatory… more
- Tecomet (Woburn, MA)
- …the training initiatives and document control and records to ensure compliance to FDA , Global Regulatory bodies and ISO requirements. Training includes but is not ... and records to ensure documentation procedures are maintained based on FDA /ISO and Corporate standards and regulations. **ESSENTIAL FUNCTIONS:** + Coordinates the… more
- Hologic (Marlborough, MA)
- …representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a ... Regulatory teams to provide security input for audits and FDA submissions. + Maintain current knowledge of FDA... FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards,… more
- Sanofi Group (Cambridge, MA)
- …and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion ... market access, and press materials. Submits materials on form FDA 2253 when applicable. + Provides US RA AdPromo...US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports ... types such as original NDA/BLAs. + Direct point of contact with FDA , leads and manages FDA meetings. Manages direct reports or junior staff as needed. +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the following duties: Write Validation documents per Food Drug Administration ( FDA )/Company guidelines; draft Specification documents and Validation Plans (VPs) for ... for new and existing equipment or procedures in accordance with company and FDA regulations; define and own all necessary change control objectives to decommission… more
- Philips (Cambridge, MA)
- …development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance ... 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA 's guidance documents, and including requirements that are relevant to the overall… more
- Philips (Cambridge, MA)
- …preparation, assembly, review and publication of regulatory submissions to the FDA , EU and other worldwide government agencies. Ensure regulatory submissions are ... required. + Your skills include knowledge of quality system requirements and FDA and/or International product approval process, demonstrate a track record in… more
- Candela Corporation (Marlborough, MA)
- …and maintainability trends . Operate Sustaining Engineering activities in an FDA regulated environment that meets internal quality requirements and regulatory ... standards for Class I/II medical devices ( FDA 21 DFR 820.30, ISO 14791, IEC 62304, IEC...product support/development environment is preferred. . Working knowledge of FDA , EU, IEC, AAMI, and ANSI standards relating… more