- Philips (Cambridge, MA)
- The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post ... proposal for balancing the project risk to project teams and Regulatory Affairs Management. + Lead communication and negotiation efforts with regulatory… more
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …is to make people's lives healthier, safer, and more fulfilling.** **Job Description** The Specialist , I - Regulatory Affairs will support the maintenance of ... EU MDR technical documentation and conduct other elements of sustaining Regulatory Affairs including maintaining "state of the art". In addition, this position… 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
- Philips (Cambridge, MA)
- …+ This role will oversee a variety of different programs within Ultrasound Regulatory Affairs ; and will drive these programs from inception to completion. ... an equivalent combination of education and relevant work experience. Medical device regulatory experience required with experience with US and global medical device… 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
- Veterans Affairs, Veterans Health Administration (Boston, MA)
- …influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus Disease 2019 ... standards, assures that the program area is compliant with all regulatory and accrediting body requirements, designs and implements orientation and training… more
- AbbVie (Waltham, MA)
- …discovery, statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and liaison with other corporations when ... candidates Purpose: The Associate Medical Director/Associate Scientific Director provides specialist medical/scientific strategic and operational input into core medical… more
- AbbVie (Cambridge, MA)
- …in Cambridge, MA preferred. Will consider remote candidates. Purpose Provides specialist medical and scientific strategic and operational input into core medical ... affairs activities such as: healthcare professional/provider interactions (HCPs, Patients...into and influences the development of asset strategy. Provides specialist medical insights, and executes on data generation, communication,… more
- Beth Israel Lahey Health (Boston, MA)
- …just taking a job, you're making a difference in people's lives.** The Regulatory Specialist supports regulatory compliance for oncology clinical research ... required in Life Science or related field.. Master's degree preferred in Regulatory Affairs + 1-3 years related work experience required. + Must demonstrate good… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …with all Joint Commission, American Academy of Sleep Medicine, and other regulatory bodies prescribed standards. Assist in ordering sleep lab equipment. Provide ... track patient compliance and creates reports for the sleep specialist to review in clinic Work Schedule: Full Time,...program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus… 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
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... than @Olympus.com, it is likely not legitimate. **Job Description** The training specialist will support the management of the global training process by… 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
- Gentiva (Auburndale, MA)
- …regulations and compliance + Registered Nurse required, BSN preferred + Strong regulatory affairs and governance requirements for healthcare + Thorough knowledge ... day. **Overview** We are looking for an **Executive Director Specialist RN** that will travel to many of our...of state and local guidelines that govern regulatory processes for healthcare + Able to travel up… more
- Olympus Corporation of the Americas (Westborough, MA)
- …complaint handling process, health hazard assessments, and other relevant quality/ regulatory documents. + Support post market counteractions related to infection ... prevention or medical device reprocessing and communication with regulatory agencies. + Identify key strategic partners for endoscope reprocessing and infection… 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 ... focus areas of this position include development and oversight of the regulatory coompliance program. This includes: Corrective Action Plan (CAP) management, … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …chemistry, analytical development, drug product development, manufacturing, quality assurance, and regulatory affairs , to develop and implement effective process ... or business processes. + Responsible for authoring relevant sections of regulatory documents, validation plans, development reports, process flow diagrams (PFDs),… more