- 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
- Dana-Farber Cancer Institute (Boston, MA)
- The Regulatory Affairs Specialist (RAS) positions provides advanced expertise and regulatory support to 600+ investigators and research staff members at ... of select protocol and monitoring processes prior to IRB review. The Regulatory Affairs Specialist (RAS) positions are critical to successfully achieving… 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
- 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 ... **Position Summary:** The incumbent will manage the regulatory process, both domestic and international markets, for NxStage Medical, Inc. products and provide … 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
- Teleflex (Chelmsford, MA)
- Clinical Affairs Specialist -MCS (Remote) **Date:** Aug 21, 2024 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : More than 50% ... that make a difference in patients' lives. **Position Summary** The Clinical Affairs Specialist augments the sales process for the Teleflex Intra-Aortic… more
- Veterans Affairs, Veterans Health Administration (West Roxbury, MA)
- …position. Position Description Title/PD#: Supervisory Health System Specialist /PD03274A Relocation/Recruitment Incentives: Not Authorized Financial Disclosure ... of health care delivery systems; regulations and standards of various regulatory and credentialing groups; and government-wide, agency, and facility systems and… more
- AbbVie (Cambridge, MA)
- …level will be determined by the qualifications listed below. 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
- 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
- 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
- Novo Nordisk (Lexington, MA)
- …Are you ready to make a difference The Position The Clinical Pharmacology Specialist can be accountable for the Clinical pharmacology strategy for phase 1-4 in ... Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory , Data Science (statistics, pharmacometrics), Research and Early Development,… 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
- ThermoFisher Scientific (Waltham, MA)
- …Chain: Planning & Sourcing + Quality: Quality Engineer, Quality Assurance, Regulatory Affairs + Distribution/Logistics: Distribution/Logistics Specialist + ... Procurement: Direct Category Management, Indirect Category Management, Procurement Excellence **Start Date:** The **OLDP** is set to begin July 14, 2025 and individuals are responsible for finalizing housing and transportation prior to program commencement and… more
- Pacific Northwest National Laboratory (Boston, MA)
- …including unmanned aerial systems (UAS). This includes legal and regulatory frameworks, identification and interdiction of threat materials, physical security, ... an ability to understand the complexity of different cultures and foreign affairs . **Hazardous Working Conditions/Environment** + The position may be subject to… 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 content expert on State and Federal Grievance and Appeal regulations for all CCA products. -… 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