- 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 other applicable laws, regulations, and standards. **Qualifications:** + BA/BS or equivalent professional work experience + A minimum of (5+ years desired) full-time experience in PACS System Administration (FUJIFILM Synapse preferred) or equivalent… 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 other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience: + 8+ years of… more
- Sanofi Group (Cambridge, MA)
- …+ Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development. + Provide medical ... in which pharmaceutical organizations function including but not limited to FDA , OIG, DDMAC/OPDP,PhRMA,ICMJE,ISPOR). + Oversee conduct of all clinical studies in… more
- J&J Family of Companies (Danvers, MA)
- …debuggers and laboratory test equipment such as oscilloscopes etc. + Knowledge of regulatory ( FDA , EPA) and quality processes. + Experience with software ... or membership in any other category protected under law. Abiomed maintains a drug -free workplace. Johnson & Johnson is an Equal Opportunity Employer. All qualified… more
- Compass Group, North America (Boston, MA)
- …and Quality Assurance programs, ensuring strictly compliant operations that meet FDA , USDA, and corporate standards. **Key Responsibilities:** + Compliance & ... Identify deficiencies and implement Standard Operating Procedures (SOPs) to ensure regulatory compliance. + Audits & Traceability: Pivot without losing momentum to… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death &… more
- ThermoFisher Scientific (Tewksbury, MA)
- …Must be able to pass a comprehensive background check, which includes a drug screening. **Key Responsibilities and Functions:** + Serve as the Principal Product ... guidelines of product development and mechanical engineering while satisfying applicable regulatory and quality requirements. + Incorporate principles of Build for… more
- J&J Family of Companies (Danvers, MA)
- …with the human factors engineering process (research, planning, risk assessment, and regulatory submissions) and principles (task and use-related risk and root cause ... and/or suggestions for improvement + In depth knowledge of FDA , ISO, AAMI, and other relevant usability regulations and...any other category protected under law. Abiomed maintains a drug -free workplace. Johnson & Johnson is an Equal Opportunity… more
- Stantec (Boston, MA)
- …related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, ... in conformity with specifications, design intent and client/user and regulatory requirements. Working under the guidance of Director of commissioning/validation,… more
- Danaher Corporation (Boston, MA)
- …also possess previous experience in: + Drug Development sales cycle and regulatory approval framework ( FDA ) + cGMP manufacturing + Sales Coaching and Value ... Selling experience Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.… more