- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance and advice… more
- Fujifilm (Boston, MA)
- …in approach and communications. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... **Position Overview** The Director of Product Marketing, Enterprise Imaging manages our go to market strategy and needs for portfolio of products we sell into the… more
- Fujifilm (Boston, MA)
- …for the position. Other + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... sales volume and Company profitability. Critical to this role is the Regional Director , Information Systems Sales' ability to effectively lead and partner with all… more
- AbbVie (Waltham, MA)
- …regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by AbbVie plants or by third-party manufacturers, ... Quality Assurance strategy and implements agreed strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as… more
- Guidehouse (Boston, MA)
- …particularly for specialty medications (eg, high cost, biologics, CAR-T, REMs, drug - device combinations), Organizational design and change management, and ... design, implementation, and monitoring services to pharmaceutical, biotechnology, and medical device , companies. We support our clients across the lifecycle of a… more
- Fresenius Medical Center (Lawrence, MA)
- …and leading a team of software developers to deliver high quality medical device software. Develop and drive a long-term strategic vision for the software team. ... software development, verification, and standards necessary to meet global medical device regulatory requirements. + Clear understanding of Software Development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Company-wide patient safety expert for assigned pharmaceutical / biological / drug - device combined products, accountable for the safety strategy and major ... + At least 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance, with both investigational and marketed products. + At least 3… more
- Cytel (Cambridge, MA)
- …and innovative services by leading engagements for pharmaceutical, biotech and device clients, and building and maintaining successful long-term relationships with ... in related areas (adaptive designs, clinical development, data science, model-informed drug development), to provide strategic advice to define optimal regulatory,… more
- Danaher Corporation (Boston, MA)
- …and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process. Travel, Motor Vehicle ... in the Biopharma sector. This position reports to the Director , Regulatory Affairs and is part of the Global...and international regulations. + Assess the impacts of relevant drug and diagnostic regulations on the development and registration… more
- Fujifilm (Boston, MA)
- …within the United States. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... **Position Overview** This position reports into the National Director of Business Development and is the primary...a Master's degree. + Minimum 8 years of medical device industry experience in a clinical capacity (clinical demonstration… more