- Fujifilm (Boston, MA)
- …to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more
- Boston University (Boston, MA)
- …of IRB-approved research studies to ensure that research is conducted in compliance with applicable regulations, policies, and guidance. These include both for-cause ... the QA role, this individual will provide assistance to clinical researchers regarding regulatory aspects to the conduct of research throughout the life of the… more
- Takeda Pharmaceuticals (Boston, MA)
- …standards and pipelines for multiple third-party vendors, ensuring data integrity, compliance , and alignment with regulatory and business requirements. + ... analysis plans, CRFs, study reports) and processes. + Strategic knowledge of FDA and ICH regulations and industry standards and quality control principles. +… more
- Cardinal Health (Peabody, MA)
- …employee development as a player-coach, which includes training, coaching, counseling, regulatory compliance , and completion of performance appraisals for ... to optimize cost effectiveness + Responsible for Cardinal Health compliance and regulations concerning OSHA, DEA, FDA ,...Health compliance and regulations concerning OSHA, DEA, FDA , State and local authorities + Coordinate maintenance of… more
- North Coast Seafoods (Boston, MA)
- …production staff and the Quality department for all Quality, Food Safety and Regulatory issues + Responsible for filling out assigned HACCP compliance documents ... Test and record measurements of seafood product attributes + Communicate quality or compliance concerns with urgency to QA leadership + Performs other related duties… more
- Robert Half Technology (Boston, MA)
- …environments (on-premise, cloud, and virtualized infrastructure). * Maintain security protocols in compliance with FDA , HIPAA, and GxP standards. * Develop ... Ideal candidates will have a deep understanding of the biotech sector's compliance requirements and the agility to adapt to a fast-paced innovation-driven… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... partners to ensure the highest level of quality and compliance with respect to ISCR processing and reporting. The...entry processing, from start to finish (QC, medical review, regulatory submissions) + Prior clinical or post marketing experience… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... diagnosed per year, number of hepatologists). + Adheres to company and compliance guidelines, policies, and procedures. + Effective communication within FUJIFILM IVD… more
- Stantec (Boston, MA)
- …related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in ... and automated systems which require qualification and validation for compliance . The commissioning and validation of equipment, facilities, utility systems… more
- Capgemini (Burlington, MA)
- …will drive verification strategies, manage a team of engineers, and ensure compliance with medical device regulations. **Your Role** . Lead Verification Strategy: ... for embedded firmware, mobile applications (iOS/Android), and integrated systems. . Compliance & Standards: Ensure all verification activities align with relevant… more