- Catalent Pharma Solutions (Chelsea, MA)
- …Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements + Prepares standard operating procedures for new and existing control ... databases and process automation protocols + Preferred experience working in FDA regulated operation in the pharmaceutical/biotech field + Physical requirements:… more
- Sanofi Group (Framingham, MA)
- …assessments, and serve as the primary liaison with regulatory authorities including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams ... for regulatory authorities** + Act as direct liaison with agencies like US FDA and EMA + Develop positive relationships with regulators + Support strategic… more
- Philips (Cambridge, MA)
- …including medical devices, with a strong understanding of laws enforced by the FTC, FDA , EPA, CPSC, the Lanham Act, and California Proposition 65. Proven ability to ... include a strong knowledge of key regulatory frameworks such as the FTC, FDA , CPSC, Lanham Act, state consumer protection laws, and the Robinson-Patman Act.… more
- Nanobiosym, Inc. (Cambridge, MA)
- …the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with details ... process control + Electromechanical experience is required + Recent experience with an FDA regulated (21 CFR 820) and/or ISO 13485 environment + Good communication… more
- Spindrift (Newton, MA)
- …of 1-3 years of food safety experience, with experience in HACCP, GMP, USDA, or FDA preferred. + A minimum of 1-year of sensory panel management in the beverage ... experience in food/beverage industry. + Previous experience with SQF, ISO, GFCO, and/or FDA audits desirable + Able to work with limited supervision + Has excellent… more
- Edwards Lifesciences (Boston, MA)
- …MEDDEV 2.7/1 and EU MDR for clinical evaluations. + Familiarity with FDA PMA applications. + Good knowledge of scientific research methodology, device development ... process, GCP, ICH guidelines and Global (US FDA , EU MDR) regulations. + Experience working in a cross functional, collaborative environment and comfortable… more
- Philips (Cambridge, MA)
- …and IT performance optimization projects. + Ensure all solutions comply with FDA validation and regulatory requirements. + Monitor and report on key performance ... in information technology engineering or computer science. + Strong understanding of FDA validation, ITIL processes, and regulatory compliance. + You must be able… more
- Bristol Myers Squibb (Devens, MA)
- …Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines ( FDA , EU) and the know how to work and manage within a regulatory ... environment. + Demonstrated leadership skills and the ability to negotiate in a complex environment. + Excellent verbal and written communication skills. + The ability to plan and lead small and medium size projects and enhancements. + Self-driven and capable… more
- System One (Boston, MA)
- …in the preparation of all documents/files/binders/electronic data for sponsor-initiated or FDA audits #m3 Ref: #558-Scientific System One, and its subsidiaries ... including Joule, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality.… more
- Tufts Medicine (Boston, MA)
- …and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines. 8. Identifies and resolves problems with protocol ... compliance by notifying investigator and as necessary with the protocol sponsor. 9. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator. 10. Participates in site visits with the study sponsor… more