- Sanofi Group (Cambridge, MA)
- …teams + Formulates and presents strategies for health authority interactions, including FDA and EMA meetings + Establishes specific project goals monthly in ... Responsibilities** + Reviews and validates clinical data compliance with FDA , EMA, and ICH regulatory standards through weekly data...in compliance with current regulations, laws, and guidance from FDA , EMA, and CHMP, as well as with Sanofi's… more
- Dana-Farber Cancer Institute (Boston, MA)
- …unit will support interventional studies to the IRB as well as assist with FDA submissions and IND management. Reporting to the CTIP Associate Director for Reg unit, ... to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA) + Support the maintenance of the… more
- J&J Family of Companies (Danvers, MA)
- …calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part 820). **Equipment Selection & Acquisition** + Partner ... compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part 820). **Qualifications / Requirements:**...or manager-level role + Familiarity with ISO 13485 and FDA QSR/21 CFR Part 820; experience with calibration standards… more
- North Coast Seafoods (New Bedford, MA)
- …work. + Safety & Compliance: Enforce safety regulations and compliance with OSHA, FDA , USDA, and GMP standards in a seafood manufacturing environment. + Inventory ... of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer… more
- Sanofi Group (Cambridge, MA)
- …The intern will engage in literature review, case study analysis of an FDA or EMA-approved gene therapy, and exploration of advanced statistical techniques relevant ... an in-depth case study analysis of a gene therapy approved by the FDA or EMA, including trial design, statistical strategy, and regulatory feedback. + Explore… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... for investigational, marketed product submissions (IND/IMPD/NDA/MAA/DMF, post-approval supplements) for FDA and equivalent submissions for Europe and Canada. +… more
- Lilly (Boston, MA)
- …Support / assist in the preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports ... (PADERS), preparation for FDA communication and resolution of regulatory issues, including regulatory...to regulatory scientists. + Participate in face-to-face meetings with FDA , EMEA and other regulatory bodies + Participate in… more
- Oracle (Boston, MA)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… more
- Oracle (Boston, MA)
- …to understanding healthcare regulatory requirements (such as HIPAA, HITRUST, FDA , etc.) and guiding cross-functional teams to systematically integrate those ... that impact software development and release management (eg, HIPAA, HITRUST, FDA ). Collaborate with engineering, risk & compliance, cybersecurity, and operations… more
- Oracle (Boston, MA)
- …Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). ..... Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical… more