- Sanofi Group (Cambridge, MA)
- …a manner that advances the company's strategy while addressing legal and regulatory risks and preserving and protecting the company's integrity and reputation. The ... highly valued. Ability to identify potential legal issues (focusing on promotional matters, regulatory issues and fraud and abuse) as well as proposed solutions to… more
- Fujifilm (Boston, MA)
- …others. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... with our MI Marketing Operations team, product owners, sales leadership, finance, quality assurance, legal and order management. The CPQ Product Marketing Manager… more
- Fujifilm (Boston, MA)
- …consistently high level of customer satisfaction. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that ... with MI Project Management (PM) team to deliver high quality Synapse product solutions. + Act as primary technical...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- ThermoFisher Scientific (Plainville, MA)
- …facts; draw valid conclusions; and make decisions. + Thorough understanding of regulatory guidelines ( FDA , EMA, and other relevant authorities). + Excellent ... organization (CDMO) that is seeking experienced individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed… more
- Bristol Myers Squibb (Devens, MA)
- …Coordinate and prepare for Material Review Board (MRB) meetings by: + Monitoring quality events and impact assessments, supporting the MRB Coordinator as needed, for ... + Own and manage MRB outputs, action items, and Quality records. + Record and manage MRB action items...to research, understand, interpret and apply internal policies and regulatory guidelines + Proficient computer skills with knowledge of… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …a New England state (ME, VT, NH, MA, CT, RI).** The Office of Data Quality (ODQ) provides research support to the Dana-Farber/Harvard Cancer Center with a focus on ... quality assurance, quality control, and process improvement....DF/HCC website. + Ensuring training resources are updated with regulatory /policy changes. + Identifying where additional modules are needed… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the effectiveness of training, continuously improve materials in collaboration with quality and training groups, and perform personnel qualifications on critical ... swab sampling. Maintain and report qualification status, address gaps, and support quality systems through CAPAs and Change Controls. Present the training process… more
- Hologic (Boston, MA)
- …service delivery for medical device products, driving customer satisfaction, regulatory compliance, and operational excellence throughout the district. **Key ... **Compliance & Safety** + Ensure all service activities comply with company policies, FDA regulations, and relevant standards (ISO, OSHA). + Promote and enforce a… more
- Fujifilm (Boston, MA)
- …of the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more
- J&J Family of Companies (Danvers, MA)
- …mechanical, and systems engineers. + Collaborate closely with software, systems, quality , regulatory , manufacturing, and clinical teams. **Product Development** ... portfolio and platform investments. + Represent Abiomed in audits, regulatory discussions, and supplier/partner engagements. **Qualifications** _Required:_ + Bachelor's… more