- Nanobiosym, Inc. (Cambridge, MA)
- …testing. + Support regulatory and quality processes with a focus on FDA and ISO 13485 compliance . Minimum Qualifications: + Master's Degree in Electrical ... experience in product development environments. + Strong understanding of compliance standards in regulated industries (eg, FDA ,...of compliance standards in regulated industries (eg, FDA , ISO 13485). + Proven track record of delivering… more
- Biomat USA, Inc. (Worcester, MA)
- …the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations ... staff during assigned shifts. + Learns and maintains thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). + ... approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or… more
- Sanofi Group (Cambridge, MA)
- …are conducted in compliance with current regulations, laws, and guidance from FDA , EMeA, and CHMP, as well as with Sanofi's policies and procedures. **About ... program strategy and the network of collaborators from research to operational, regulatory , and commercial functions. Success in this role requires the ability to… more
- Sumitomo Pharma (Boston, MA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties… more
- ThermoFisher Scientific (Plainville, MA)
- …2-3 years experience leading teams in a fast-paced environment required. + Experience with regulatory inspections from the FDA , EMA, Health Canada, or other ... & Analytics to the cGMP QC testing laboratory. The manager ensures cGMP compliance , operates within budgets, and supervises bioanalytical lab staff directly and QC… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …institutions for clinical and non-clinical Dana-Farber research projects 3. Identify regulatory compliance , legal, intellectual property, and other risks in ... with applicable laws, regulations, Institute's policies, and guidelines. + Identify regulatory compliance , legal, intellectual property, and other risks in the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management and serious breach process. This role focuses ... This position supports Takeda's mission by maintaining high standards of quality and compliance in clinical trials. **This role is located in Cambridge, MA and is… more
- Charles River Laboratories (Wilmington, MA)
- …customer training, and product validations. * Responsible for completing all service and compliance documentation as required by company policy, cGMP and FDA . * ... quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.… more
- Spindrift (Newtonville, MA)
- …law, trademark/IP, employment law, and privacy/data protection + Familiarity with FDA /FTC regulatory frameworks for food/beverage marketing + Excellent judgment ... website copy and marketing materials + Advise on FTC, FDA , and related regulations for food & beverage products...website content + Advise on consumer data privacy, including compliance with applicable laws (eg, CCPA, CPRA, GDPR) +… more
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