- Dana-Farber Cancer Institute (Brookline, MA)
- …to the DF/HCC website. + Ensuring training resources are updated with regulatory /policy changes. + Identifying where additional modules are needed and promoting ... Expert knowledge of federal regulations regarding human subject research protections, FDA and ICH Good Clinical Practices. **Pay Transparency Statement** The hiring… more
- ThermoFisher Scientific (Tewksbury, MA)
- …guidelines of product development and mechanical engineering while satisfying applicable regulatory and quality requirements. + Incorporate principles of Build for ... with consideration for workflow, assembly, and process. + Experience in FDA -regulated industries, including familiarity with cGMPs. + Comprehension of business… more
- Bristol Myers Squibb (Devens, MA)
- …+ Ability to research, understand, interpret and apply internal policies and regulatory guidelines + Proficient computer skills, with knowledge of digital tools such ... demonstrated experience with Change Control and Risk Management. Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.… more
- Charles River Laboratories (Shrewsbury, MA)
- …with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- Tufts Medicine (Boston, MA)
- …policies and government regulations pertaining to human subjects protections. Maintains regulatory binders, case report forms, source documents, and other study ... and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines. 8. Identifies and resolves problems with protocol… more
- Charles River Laboratories (Wilmington, MA)
- …quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies. ... proudly supported the development of ~85% of the drugs approved by the FDA in 2019. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- Bristol Myers Squibb (Devens, MA)
- …+ Ability to research, understand, interpret, and apply internal policies and regulatory guidelines + Proficient computer skills with knowledge of several digital ... environment with limited information and/or time-constraints. + Experience in FDA /EMA regulations in biopharmaceuticals or cell therapy manufacturing is required.… more
- Charles River Laboratories (Shrewsbury, MA)
- …with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- J&J Family of Companies (Danvers, MA)
- …with the human factors engineering process (research, planning, risk assessment, and regulatory submissions) and principles (task and use-related risk and root cause ... disposition feedback and/or suggestions for improvement + In depth knowledge of FDA , ISO, AAMI, and other relevant usability regulations and standards. Knowledge of… more
- Medtronic (Newton, MA)
- …**Preferred Qualifications** + Knowledge of Medical Product verification, IEC-62304 and FDA guidance in a technical discipline, preferably software related + Strong ... etc.) + Ability to work with QA to ensure testing meets Quality and Regulatory needs. + Ability to manage, track and upgrade multiple hardware and software… more