- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... **Position Overview** The Account Manager - Oil & Gas position will be...our technical staff for exposure information, problem solving and product testing at current and potential customers. + Communicate… more
- Bristol Myers Squibb (Devens, MA)
- …and EU cGMP regulations and guidance. + Knowledge and proven experience in FDA , EMA, or other regulatory authority. + Demonstrated leadership, interpersonal, ... at BMS with our Cell Therapy team. The **Senior Manager , Quality Assurance Investigations** at the Cell Therapy Facility...site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and… more
- Rhythm Pharmaceuticals (Boston, MA)
- …quarterly business reviews of programs + Ensure all speaker programs adhere to regulatory guidelines (eg, FDA , PhRMA, Sunshine Act) + Manage documentation, ... for this role will be to act as the manager for all aspects of Speaker Bureau planning, development,...teams/HQ to promote the activities, where allowed + Lead product theaters at key congresses (materials, invitations, speaker management)… more
- Charles River Laboratories (Wilmington, MA)
- …build a career that you can feel passionate about. **Job Summary** The Account Manager I / II is responsible for achieving quarterly and annual Celsis and Accugenix ... the acceptance and use of company products and services. + Communicate available product and services and inform customers of new products and services in a… more
- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The **Senior Manager , QA Material Review Board** role is responsible for the Material Review Board (MRB) ... content for the Material Review Boards to facilitate options for delivering Drug Product to patients. The primary stakeholders for this role are QA Disposition,… more
- Bristol Myers Squibb (Devens, MA)
- …Manufacturing Practices (cGMPs). In the capacity of QA Shop Floor Support, the ** Manager , Shop Floor QA, Cell Therapy** shall be responsible for handling Quality ... issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing. + Serve as a subject… more
- J&J Family of Companies (Raynham, MA)
- …to solve complex biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety. + Interacts closely with ... consultative direction as well as technical guidance to R&D, Clinical Affairs, Regulatory Affairs, Product Stewardship, Surgical R&D and Supplier Management. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …creation and execution of Human Factors documentation to ensure compliance with regulatory requirements in alignment with the business strategy of the company. This ... need it. + Be the point of contact for regulatory body audits and communications for the region. +...+ Ensure that expert HFE input is provided to product design teams for addressing design requirements, packaging requirements,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …support Regulatory Affairs' efforts in creating submission materials for various regulatory domains including FDA , PMDA, and EU-MDR. **Job Duties** + Advise ... support across the global organization and assists development teams in applying regulatory rigor to Agile SW development practices. This position provides subject… more
- Fresenius Medical Center (Lawrence, MA)
- …DUTIES AND RESPONSIBILITIES** . Works as part of software development team on new product development or on design changes to ensure product quality and minimize ... risk to users and patients as well as regulatory and corporate SOP compliance. . Reviews and approves.... Reviews and approves design control deliverables along the product development process as well as design changes .… more