- System One (Burlington, MA)
- Title: Senior Regulatory Affairs Specialist -Animal Tissue Location: Burlington MA Schedule: Monday through Friday on site Terms: Direct Hire Education: ... animal tissue suppliers Responsibilities: Will report to the VP of Regulatory Affairs Responsible for managing all activities/tasks related to animal tissue for… more
- Danaher Corporation (Boston, MA)
- …safeguard and improve human health. This position is part of the Quality Assurance and Regulatory Affairs group located in Coralville, IA , USA and will be ... team responsible for worldwide submission activities, maintenance of approvals and global regulatory strategies, across multiple sites, in support of PMA, 510(k), de… more
- Bausch + Lomb (Boston, MA)
- …the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs , R&D, TechOps and Supply Chain as appropriate in a ... company functions during Regulatory Authority inspections. + Serve as Regulatory Affairs representative on facility/site Local Change Management Boards. +… more
- Fresenius Medical Center (Lawrence, MA)
- …or equivalent experience + 8+ years' experience in domestic and international Regulatory Affairs in the medical device industry + Experience interacting ... Canada, Europe (CE Mark), Mexico, Asia, etc. + Communicate directly with senior management, economic operators, andregulatory agencieson all regulatory issues. +… more
- Philips (Cambridge, MA)
- …role you have the opportunity to** Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory ... US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. **Your role:** + Serve as RA Representative on project teams,… more
- Commonwealth Care Alliance (Boston, MA)
- …Healthcare Compliance (CHC) preferred. + 5 or more years direct work experience in regulatory affairs and/or compliance in Medicare or Medicaid required + 5 or ... to regulators + Submit materials to regulators + Coordinate attestations from Senior Leadership for submission **Compliance Regulatory Guidance Distribution** +… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …surrounding departments such as Quality Assurance, Compliance, Technical Support, Service, and Regulatory Affairs . Involved in several aspects of Post Market ... Degree preferred + 3-5+ yrs. related experience preferred + Certification in Regulatory Affairs program Preferred Knowledge, Skills and Abilities + Has… more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- State of Massachusetts (Boston, MA)
- …environmental specialists that reviews major energy facility proposals requiring EFSB/DPU regulatory approvals. Our mission is to ensure that approved projects are ... takes place in a rapidly evolving energy landscape, with significant technological, regulatory , and market changes, and a growing emphasis on both mitigating and… more
- Commonwealth Care Alliance (Boston, MA)
- …- Interdepartmental stakeholders include but are not limited to: quality; regulatory affairs /compliance; clinical, operations, pharmacy, dental, reporting, and ... member services. - Supports the Senior Appeals & Grievance Coordinator and A/G Coordinator in day-to-day tasks and assignments. - Content Expert: Act as CCA?s… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs , to develop and implement effective process ... + Identifies topics for initiatives and leads local/global initiatives on behalf of senior staff. + Recognized as a technical leader/resource by the group and… more