- Capgemini (Burlington, MA)
- …will drive verification strategies, manage a team of engineers, and ensure compliance with medical device regulations. **Your Role** . Lead Verification Strategy: ... for embedded firmware, mobile applications (iOS/Android), and integrated systems. . Compliance & Standards: Ensure all verification activities align with relevant… more
- Teleflex (Chelmsford, MA)
- …II will be responsible for cross-functional quality assurance, quality management/ compliance , quality control, and activities associated with all Teleflex products ... vendor audits if necessary. Support the Back Room during regulatory and notified body audits. * Production & Process...QA tasks, as assigned by QA Manager. * Maintain compliance with Teleflex Global & local procedures and policies.… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and aggregate reports. This may include the support of monitoring compliance , effective communication, and implementation of corrective and preventive actions, as ... teams with PV and safety activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across programs. + Assists… more
- Dana-Farber Cancer Institute (Boston, MA)
- …clinical and operational outcomes. + Familiarity with healthcare regulations and compliance standards relevant to cel therapies including, FDA guidelines, ... and implementation of new IT architecture, ensuring scalability, security, and compliance with healthcare regulations. + Manage relationships with key stakeholders,… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... mapping for project and or post go-live support cases in compliance with the company's quality procedures. **Company Overview** At FUJIFILM Healthcare… more
- Charles River Laboratories (Shrewsbury, MA)
- …forms, tables, and hand record data. ⦁ Perform all tasks in compliance with Good Laboratory Practice Regulations (GLPs) and Standard Operating Procedures (SOPs). ... with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling… more
- Fujifilm (Boston, MA)
- …testing. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... creation and maintenance of all relevant documentation required for the purposes of compliance with applicable regulations. + Assign and track work of team members.… more
- Children's Hospital Boston (Boston, MA)
- …+ Ensures compliance with departmental quality initiatives, as well as regulatory and accreditation standards (Joint Commission, DPH, FDA , CMS). + Maintains ... professional skills and knowledge through educational programming, conference attendance, and leadership in professional organizations. Qualifications: + Minimum of a Bachelor's degree in Nutrition & Dietetics or a closely related field is required; Master's… more
- Charles River Laboratories (Shrewsbury, MA)
- …and watering devices for proper function. * Perform all tasks in compliance with Good Laboratory Practice Regulations (GLPs) and Standard Operating Procedures ... with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling… more
- Charles River Laboratories (Cambridge, MA)
- …methods. Additional responsibilities include: + Conduct laboratory procedures in compliance with established protocols/plans, regulatory and laboratory ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more