- Sumitomo Pharma (Boston, MA)
- …rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop ... goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and… more
- Philips (Cambridge, MA)
- …+ **Leads** the medical writing team in planning and delivering high- quality , compliant documents through effective resources, budget, and timeline management. + ... non-clinical evidence. + **Collaborates** with cross-functional teams to ensure regulatory compliance and to define medical writing scope and clinical evidence… more
- System One (Devens, MA)
- …targets while maintaining product quality and safety. + Maintain full compliance with SOPs, FDA cGMPs, DEA regulations, and other applicable federal, ... as a liaison between Production and departments such as Quality Control, Quality Assurance, Maintenance, and Material...a GMP environment + Strong working knowledge of GMP, FDA , and DEA regulations + Excellent communication skills and… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and NDA/IND commitments + Act as an expert resource for eCTD submissions to FDA , ensuring compliance with internal and health authority standards + Support the ... of eCTD submission-ready documents, coordinating across functions, and ensuring quality , accuracy, and adherence to regulatory guidelines. Additionally, the… more
- Charles River Laboratories (Boston, MA)
- …well-being during all phases of the animal's life as well as roles in compliance monitoring, quality management and safe work practices when working with animal ... At Charles River, we are passionate about improving the quality of people's lives. When you join our global...that relate to animal care and use (Eg, USDA, FDA , AAALAC). + Make recommendations and assist in establishing… more
- Performance Food Group (Taunton, MA)
- …of staff selection, development, discipline, performance reviews, and/or terminations to ensure compliance with safety and quality standards. + Conduct regular ... local, state, and federal regulatory agencies (ie OSHA, AIB, FDA , USDA, etc.) **Req Number:** 126068BR **Address Line 1:**...budgeting and profit and loss * Experience with OSHA, FDA , USDA and other regulatory agencies * Experience with… more
- Catalent Pharma Solutions (Chelsea, MA)
- …needs.** **Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, ... Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements + Prepares standard operating procedures for new and existing control… more
- Hologic (Marlborough, MA)
- …Device Quality Assurance:** Provide comprehensive support to ensure the quality , compliance , and safety of medical devices throughout their lifecycle, ... projects (eg, internalizations, supplier changes, value improvement projects), while maintaining quality , compliance , and safety. + ** Quality Assurance… more
- Hologic (Marlborough, MA)
- …complex issues creatively and effectively, ensuring innovative solutions align with quality and compliance standards. **Qualifications:** + Deep technical ... knowledge of **SaMD** , including regulatory requirements such as FDA 21 CFR Part 820 (Design Control), ISO 13485,...including risk management and usability + Proven expertise in ** quality systems** and compliance for regulated products,… more
- J&J Family of Companies (Danvers, MA)
- …technical mentorship to junior engineers and multi-functional team members. + Ensure compliance with all applicable ** FDA , ISO 13485, and GMP** requirements. ... Working knowledge of **industry standards** such as IPC-A-610, J-STD-001, and FDA /ISO quality system regulations. + Excellent problem-solving, technical writing,… more
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