- Grifols Shared Services North America, Inc (Worcester, MA)
- …organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of ... global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet… more
- Sanofi Group (Cambridge, MA)
- …of key regulatory framework relevant to pharmaceutical email communications (eg, HIPAA, GDPR, FDA regulations, PhRMA Code) **Why Choose Us?** + Bring the miracles of ... science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards… more
- Charles River Laboratories (Worcester, MA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. If you are interested in applying to… more
- Sumitomo Pharma (Boston, MA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- J&J Family of Companies (Danvers, MA)
- …of Medical Device Design Controls and Product Life cycle + Knowledge of FDA and EU MDR regulations + Ability to communicate ideas and information clearly, ... effectively, and frequently (oral and written) with partners, project team, local and international. + Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results. + Ability to act independently to resolve… more
- Capgemini (Burlington, MA)
- …with relevant medical device regulations such as ISO 13485, IEC 62304, and FDA guidelines. . Defect Management: Lead root cause analysis and resolution of defects, ... ensuring proper traceability and documentation. . Cross-functional Collaboration: Work closely with software, hardware, and QA teams to synchronize verification efforts with development milestones. . Tooling & Infrastructure: Select, configure, and maintain… more
- Norstella (Boston, MA)
- …to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + Support client engagements by participating in scoping discussions ... and helping design custom RWD solutions that address key clinical, regulatory, and business questions. + And other duties as assigned. **Qualifications:** + Advanced degree (Master's or Doctorate) in Biostatistics, Epidemiology, Public Health, Pharmacy… more
- Boston University (Boston, MA)
- …expenses for the CME Office. Operating within a highly regulated environment (eg. FDA , OIG, ACCME Standards for Commercial Support), the Financial Manager will work ... with other members of the CME team to ensure contract fulfillment and compliance, in addition to supporting the team with the financial aspects of their activities. The Financial Manager brings financial management acumen to the office and assists in the… more
- Fortrex (Woburn, MA)
- …450 plantas que limpia diariamente en norte America. Nosotros abarcamos USDA, FDA e instalaciones procesadoras de comida CFIA. Nuestros clientes trabajan fuertemente ... para perfeccionar sus productos y Fortrex se asegura de que esten protegidos. Fortrex es un empleador de igualdad de oportunidades. **LO QUE OFRECEMOS:** + Seguro Medico, Dental y Vision + Seguro de Vida Basico + Plan de Jubilacion 401K + Dias Festivos pagadas… more
- Teleflex (Chelmsford, MA)
- …GMPs and are auditable at all times. Assures compliance with GMP (ISO 13485, FDA 21 CFR 820, MDD 93/42EEC, and all applicable standards) * Lead discussion with ... line leaders and area employees to review production activity, operational issues, waste/scrap, and quality data to determine root cause, course of action to achieve goals, and potential process improvements. * Collaborate with pertinent departments and plant… more