- Wolters Kluwer (Waltham, MA)
- …regulatory published drug information and policy data sources (CMS, FDA , etc.) covering drug control/ compliance programs, covered programs (Medicare/Medicaid) ... Demonstrated success managing product line projects, including risk mitigation, regulatory awareness, translating customer needs into business requirements, stakeholder… more
- Hologic (Marlborough, MA)
- …while supporting product development, manufacturing-related design changes, maintaining regulatory compliance , and enhancing manufacturability and cost ... Skeletal Health (BSH) products. This role is crucial in driving sustainable compliance , optimizing QMS processes, and fostering a culture of continuous improvement.… more
- Lawrence General Hospital (Methuen, MA)
- …Quality Management activities, the educational needs of the laboratory staff and Regulatory Compliance with: The Joint Commission, College of American Pathology, ... testing performed outside the traditional laboratory environment meets both regulatory standards and the institution's quality requirements. By coordinating with… more
- J&J Family of Companies (Raynham, MA)
- …focused on customer-centric quality. + Ensure all quality activities comply with regulatory standards (eg, FDA , ISO) and internal policies, especially in ... data to improve overall customer satisfaction. + Partners with R&D, Manufacturing, Regulatory , Supply Chain, Marketing, and Customer Support teams to identify and… more
- Cognizant (Boston, MA)
- …**Required Qualifications:** * **Deep Knowledge of GxP Regulations** Strong understanding of FDA , EMA, MHRA, and other global regulatory requirements (eg, 21 ... seamless integration across platforms. * Coordinate CSV activities to ensure compliance with regulatory standards. * Utilize ALM tools to manage and streamline… more
- Hologic (Marlborough, MA)
- …IVD devices. + Proven track record in complaint investigations, CAPA processes, and regulatory compliance . + Experience in a leadership or management role, with ... Deep understanding of Quality Management Systems (QMS), including ISO 13485 and FDA QMSR regulations. + Expertise in root cause analysis, CAPA, complaint… more
- Fujifilm (Boston, MA)
- …and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in ... II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and… more
- Charles River Laboratories (Cambridge, MA)
- …(including rack sanitation, PPE/supply stations and waste management). + Ensures compliance and documentation with all institutional and regulatory protocols, ... wash team operations. + Continuously support vivarium management in maintaining compliance with all internal (IACUC) and external (USDA-APHIS, PHS-OLAW,) … more
- Rhythm Pharmaceuticals (Boston, MA)
- …office to play a key role in ensuring quality and regulation-based compliance during the manufacture and distribution of Rhythm clinical and commercial products. ... administration of quality processes and records, ensuring operational excellence in GxP compliance , and maintaining a state of inspection readiness. The Manager, QA,… more
- Bristol Myers Squibb (Devens, MA)
- …This position will oversee and partner with operational teams to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The ... procedures, and Global cGMP. Functional responsibilities include ensuring operational compliance with applicable procedures and batch records, providing real time… more