- Sanofi Group (Cambridge, MA)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development… more
- Kelly Services (Marlborough, MA)
- … regulatory compliance. + Experience with documentation systems and quality management tools. **Important information:** To be immediately considered, please send ... suppliers. The ideal candidate will also bring expertise in validation processes and FDA Design Controls and serve as a technical mentor within the organization.… more
- IQVIA (Boston, MA)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. ... area guidance for clinical development plans in compliance with applicable regulatory , medical, and ethics guidelines. + Ensure high- quality , data-driven… more
- Takeda Pharmaceuticals (Lexington, MA)
- …across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device ... into technical requirements + Coordinate risk mitigation activities across clinical, regulatory , quality , and engineering functions + Perform safety reviews… more
- J&J Family of Companies (Danvers, MA)
- …as the subject matter expert (SME) for process validation, ensuring alignment with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations and standards. ... manufacturing lines, and process changes. + Collaborate with Manufacturing and Quality Engineering to ensure validation requirements are integrated into design and… more
- Medtronic (Boston, MA)
- …product approvals. Prepare, submit, and manage regulatory filings across global regulatory agencies based on FDA and EU submissions. Provide expertise on ... world. **A Day in the Life** Job Summary: Principal Regulatory Affairs Specialist As a Principal Regulatory ...and provide guidance to internal stakeholders. Collaborate with R&D, Quality , and other teams to ensure product compliance throughout… more
- Integra LifeSciences (Braintree, MA)
- …A minimum of 2-4 years' experience in a medical device, pharmaceuticals, Quality / Regulatory Compliance, or other cGMP regulated product preferred environment. + ... and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. **ESSENTIAL...Familiarity with application of FDA and/or ISO quality standards in a… more
- Performance Food Group (Taunton, MA)
- …ensure a safe and clean warehouse. + Complies with local, state, and federal regulatory agencies (ie OSHA, AIB, FDA , USDA, etc.) **Req Number:** 126068BR ... reviews, and/or terminations to ensure compliance with safety and quality standards. + Conduct regular audits to ensure compliance...budgeting and profit and loss * Experience with OSHA, FDA , USDA and other regulatory agencies *… more
- Charles River Laboratories (Wilmington, MA)
- …an experienced professional with expertise in establishing effective scientific and regulatory strategies to advance new medicines through the various stages of ... products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in… more
- Nanobiosym, Inc. (Cambridge, MA)
- …+ Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission + Manage and contribute to regulatory documents + Project ... managerial and leadership expertise in assay development + Strong understanding of FDA and global regulatory requirements + Prefer commercial assay experience… more