- Chiesi (Boston, MA)
- …early access and compassionate use programs, ensuring compliance with varied regulatory frameworks (eg, FDA , EMA, and other health authorities). + Leverage ... narratives for global stakeholders. + Partner with R&D, clinical development, regulatory , and commercial teams to ensure seamless, consistent messaging across all… more
- Takeda Pharmaceuticals (Boston, MA)
- …processes and training and ensure alignment with global processes and regulatory requirements and expectations. + Drive the implementation and change management ... monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans + Engage with CPMQ… more
- Staples (Framingham, MA)
- …Expert to standardize, harmonize and support the execution of safety and regulatory compliance programs including: . Workplace Safety, Hazardous Substance ... Protection team to support the implementation and execution of regulatory compliance programs designed to protect the...required by OSHA, EPA, DOT, FMCSA and the US FDA . Works closely with Risk Management and field operations… more
- Hologic (Marlborough, MA)
- …and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you ... MA, United States Are you a seasoned quality and compliance professional with a passion for driving excellence in...patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO… more
- Cognizant (Boston, MA)
- …advanced degree preferred. Certifications: (Optional) ISTQB, PMP, or relevant regulatory compliance certifications. **_Roles & Responsibilities_** Develop and ... and Computer Software Assurance (CSA) processes Knowledge on ALM Test management tool Regulatory Knowledge: Strong understanding of FDA , EMA, GxP, and 21 CFR… more
- Sumitomo Pharma (Boston, MA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions,...clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with… more
- Cardinal Health (Mansfield, MA)
- …System (LIMS), such as LabWare. + Possesses significant working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability ... stability studies, and other relevant documentation to ensure accuracy and compliance . + Actively support stability studies and collaborate across departments to… more
- AbbVie (Worcester, MA)
- …accurate, secure and in full compliance with AbbVie's global program and regulatory standards including FDA , EMA and MHRA requirements. This role bridges the ... role will lead and implement a site strategy in compliance with regulatory and AbbVie global expectations,...inspections related to data integrity. + Ensure adherence to regulatory standards (e, g FDA , GxP etc.)… more
- Candela Corporation (Marlborough, MA)
- …monitor test results and defects, and generate final traceability reports, in compliance with design controls and all regulatory requirements. . Address ... regulated environment that meets internal quality requirements and regulatory standards for Class I/II medical devices ( FDA... regulatory standards for Class I/II medical devices ( FDA 21 DFR 820.30, ISO 14791, IEC 62304, IEC… more
- Insight Global (Bedford, MA)
- …a risk-based approach. - Experience with AI/ML models. - Familiarity with international regulatory landscapes beyond FDA and EU MDR. - Demonstrated judgment in ... provides leadership at the project level, guiding quality and compliance in areas like development, cybersecurity, verification/validation, and maintenance. Key… more