- Philips (Cambridge, MA)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... lives of patients around the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product… more
- Editas Medicine (Cambridge, MA)
- …leading the way towards a healthier and more equitable future. Position Summary As the Senior Manager of Regulatory Affairs , you will play a critical role in ... commercialization of our products. Key Responsibilities: As the Senior Manager , Regulatory Affairs , you will... Management tools such as SmartSheet, ThinkCell and/or Microsoft Project is key. + Regulatory Compliance: Monitor… more
- Novo Nordisk (Lexington, MA)
- …documents to regulatory agencies. Relationships Report to a Director of Regulatory Affairs . Develop and maintain positive rapport and working relationships ... with other personnel in Regulatory Affairs and other local and headquarter...submitting responses to agency queries + Create and maintain product/ project database to record history of questions asked /… more
- Medtronic (Mansfield, MA)
- …to fostering a diverse and inclusive culture. **A DAY IN THE LIFE** * Act as Regulatory Affairs representative on project transfer teams. * Plan and execute ... strategy for supplier transfer projects. You'll assess the regulatory impact of supplier transfers and lead project...**NICE TO HAVE** (Preferred Qualifications) * 4+ years of regulatory affairs experience strongly preferred * 4+… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and ... various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines...to support their development + May serve as direct/matrix manager of RAV CMC staff, depending on project… more
- Fresenius Medical Center (Waltham, MA)
- This position can be fully remote. **PURPOSE AND SCOPE:** Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions ... and systems designed to ensure the product development process addresses all regulatory requirements as well as the objectives of the business. **PRINCIPAL DUTIES… more
- Fresenius Medical Center (Waltham, MA)
- This position can be fully remote Global Regulatory experience needed. Demonstrated project management experience needed. **PURPOSE AND SCOPE:** Ensures company ... products meet regulatory requirements by supporting all assigned regulatory ... representative on interdepartmental pharmaceuticals development teams. + Provides project team representation and direction in managing information from/to… more
- Veterans Affairs, Veterans Health Administration (Brockton, MA)
- …Duties include, but are not limited to: Collaborates with the chief and engineer manager in the establishment of overall goals and objectives and works closely with ... project engineers and technicians and the using services to...program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus… more
- Beth Israel Lahey Health (Boston, MA)
- … and Accreditation Program Manager reports to the Director, Regulatory Affairs . Manages the accreditation/ regulatory program requirements related ... people's lives.** Under the direction of the Director of Regulatory Affairs , the Performance Assessment and ...quality and safety survey coordination and compliance. Acts as project resource and partner with the project … more
- Harvard University (Cambridge, MA)
- …Resources for Trials IRB Reliance platform (SMART IRB) system, the Harvard Office of Regulatory Affairs and Research Compliance (ORARC), the HLC IRB, and the ... Administration Position Description: The Epidemiology Department is seeking a Regulatory and Compliance Manager for all PHACS-affiliated research… more
- Boston University (Boston, MA)
- …- 8 years relevant experience working as a clinical research coordinator role ( project manager , research assistant, study coordinator, etc.) and/or working as an ... to best practices. The Clinical Research Resources Office (CRRO) Regulatory Education Manager will manage two important...within the CRRO (under the Office of Human Research Affairs ) as well within the BU Clinical and Translational… more
- Eversource Energy (Westwood, MA)
- …and budgets in the conceptual phase prior to execution + Interacts regularly with Regulatory Affairs , Environmental Affairs , and Energy Efficiency to develop ... three months in the office\. Eversource is looking for a **Senior Program Manager , Strategic Project Development, Transmission** located in **Hartford, CT** or… more
- Eversource Energy (Westwood, MA)
- …and budgets in the conceptual phase prior to execution + Interacts regularly with Regulatory Affairs , Environmental Affairs , and Energy Efficiency to develop ... **Our Team** Eversource is looking for a **Senior Program Manager , Strategic Project Development** located in **Hartford, CT** or **Westwood, MA** or **Hooksett,… more
- Beth Israel Lahey Health (Beverly, MA)
- …and Lynn. Beth Israel Lahey Health is seeking a dynamic Hospital Construction Project Manager to lead transformative projects for our highly rated hospitals ... the North Shore of Massachusetts. As a Hospital Construction Project Manager , you'll play a pivotal role...work streams such as IT, HR, medical equipment and regulatory affairs . Oversee establishment of package specific… more
- Blue Cross Blue Shield of Massachusetts (Boston, MA)
- …healthcare? Bring your true colors to blue. What We Need The Senior Project Manager , Scrum Master will be responsible for supporting complex projects/products ... the organization and corporate strategy. + You will be part of the Government Regulatory Affairs (GRA) Solutions team that oversees all projects within the GRA… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... date on the latest global regulations. + Collaborate closely with the Quality, Regulatory , R&D, Business Development, Medical & Scientific Affairs , IT, and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …of the following Clinical Development functions in support of IT - Medical Affairs , Regulatory Affairs , Global Patient Safety, Clinical Operations, BioStats ... The Business Analysis & Operations Senior Manager will drive consistency across the Global Development...frameworks to bring together accurate, measurable requirements that drive project outcomes. + Create flexible processes & frameworks in… more
- Philips (Cambridge, MA)
- …Management, you will work in a dynamic organization that includes Quality, Regulatory Affairs , Medical Office, Compliance, Quality Services, and Transformations. ... quality/ regulatory standards. **Your role:** + The Senior Program Manager provides program leadership and execution of patient safety and quality… more
- Medtronic (Boston, MA)
- …balancing time, schedule, cost, and quality, while adhering to safety and regulatory standards. + Manage project financials, including forecasting and tracking ... **CAREERS THAT CHANGE LIVES:** Join Medtronic as a Program Manager in our Robotics Surgical Technology (RST) Released Product Engineering (RPE) Project … 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