- Hologic (Marlborough, MA)
- …implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If ... patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO...(eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems and GMP… more
- Staples (Framingham, MA)
- …to positively influence associate and customer safety, as well as minimize regulatory risks and exposures. This role will enhance operating efficiencies through ... to standardize, harmonize and support the execution of safety and regulatory compliance programs including: . Workplace Safety, Hazardous Substance management… more
- Sanofi Group (Cambridge, MA)
- …compliance with all corporate and industry policies and legal and regulatory requirements, for all medical affairs activities + Ensure promotional/non-promotional ... include major assets, sound medical advice that minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the following duties: Write Validation documents per Food Drug Administration ( FDA )/Company guidelines; draft Specification documents and Validation Plans (VPs) for ... for new and existing equipment or procedures in accordance with company and FDA regulations; define and own all necessary change control objectives to decommission… more
- Boston University (Boston, MA)
- …the QA role, this individual will provide assistance to clinical researchers regarding regulatory aspects to the conduct of research throughout the life of the ... QA reviews. The incumbent will work with the CRRO Regulatory Education Manager and others within the Human Research...understanding of policies and regulations guiding human research, including FDA , OHRP, ICH GCP, applicable NIH policies, etc. +… more
- Fujifilm (Boston, MA)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... in the development and structuring of new business ventures. + Keep abreast of legislative and regulatory changes that may affect HLUS and its subsidiary companies.… more
- Philips (Cambridge, MA)
- …and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. 4, EU Medical Device Regulation). + **Author** and ... + **Drives** collaboration and knowledge-sharing across medical, clinical, and regulatory teams, including Medical Affairs, Clinical Development, Research &… more
- Catalent Pharma Solutions (Chelsea, MA)
- …Perform various quality assurance checks during all manufacturing processes; Assess regulatory and quality risks in manufacturing activities and processes according ... to regulatory agency rules and guidelines; Conduct quality audits of...validation procedures in accordance with Quality System Regulations (QSR), FDA and international guidelines; Analyze and identify root causes… more
- Charles River Laboratories (Shrewsbury, MA)
- …of continuous improvement in site operations and ensure successful audits by regulatory agencies. Duties also include delegated activities as per the individual's ... training programs, including orientation. * Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs,… more
- Kelly Services (Marlborough, MA)
- …suppliers. The ideal candidate will also bring expertise in validation processes and FDA Design Controls and serve as a technical mentor within the organization. ... components and systems. + Develop and maintain documentation in alignment with FDA Design Controls, including design inputs, outputs, and traceability. + Create and… more