- Beth Israel Lahey Health (Burlington, MA)
- …aspects of clinical trials research adhering to Research SOPs, GCP compliance and FDA regulations. 2) Functions as a mentor, resource and educator for clinical ... computer systems, including web based applications; Working knowledge of medical terminology, FDA , OHRP and GCP regulations and medical practice protocols; In the… more
- Takeda Pharmaceuticals (Boston, MA)
- …stakeholders within the organization and externally with platform vendors, RWE innovators, FDA etc. + Act as a knowledge developer and repository around ... observational studies, FDA policies, publications etc related to RWE. + Be at the forefront of advanced technologies like Gen-AI/agentic AI and their applications of… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …understanding of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory ... etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for… more
- Element Materials Technology (Acton, MA)
- …Join Element's **Santa Fe Springs laboratory** , an FDA -registered, ISO/IEC 17025-accredited facility specializing in **pharmaceutical testing, trace-metal ... + Interpret and communicate complex testing protocols, regulatory requirements ( FDA , ISO/IEC 17025), and client specifications to develop compliant cost… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Kelly Services (Braintree, MA)
- …OOS investigations, non-conformances, and CAPAs. + Prepare for and participate in FDA and customer audits. **What You'll Bring:** + Bachelor's degree in ... + Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). + Familiarity with FDA and/or ISO quality standards (ISO 13485 preferred). + Ability to follow… more
- Deloitte (Boston, MA)
- …Compliance: Ensure all solutions and processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and industry best practices. + Data Analysis & Reporting: ... (Word, Excel, Power Point) + Knowledge of global regulations and guidelines such as ICH, FDA , EMA, PMDA, etc. + Ability to travel 50%, on average, based on the work… more
- Nanobiosym, Inc. (Cambridge, MA)
- …functional testing. + Support regulatory and quality processes with a focus on FDA and ISO 13485 compliance. Minimum Qualifications: + Master's Degree in Electrical ... + Strong understanding of compliance standards in regulated industries (eg, FDA , ISO 13485). + Proven track record of delivering production-quality PCBs-from… more
- LGC Group (Milford, MA)
- …LGC Proficiency Testing a global leader in PT schemes. We operate FDA -registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland ... who is experienced with a working knowledge of quality system requirements, including FDA QSR/cGMP, ISO 13485 and ISO 14971. The successful candidate will have a… more
- Spindrift (Newton, MA)
- …Requirements + Previous food safety experience, with experience in HACCP, GMP, USDA, or FDA preferred. + Previous experience with SQF, ISO, GFCO, and/or FDA ... audits desirable + Excellent verbal and written communication skills + Thrives in an entrepreneurial environment and considers no task too small nor too large + Consistently demonstrates accuracy, thoroughness and dependability + Establishes and maintains… more