- Sumitomo Pharma (Boston, MA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- Cardinal Health (Mansfield, MA)
- …analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA ). + Perform investigations of Out of Specification (OOS) test results as ... needed follow FDA guidelines. + Maintain compliance with relevant regulatory requirements...the data by team members. + Work with lab manager and senior staff members of pharmaceutical analysis department,… more
- Dana-Farber Cancer Institute (Boston, MA)
- …works under the direction of the Breast Oncology Principal Investigator(s), Regulatory Operations Manager , Clinical Research Manager and / or directly for the ... Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory… more
- North Coast Seafoods (Boston, MA)
- …Boston. This role serves as the bridge between the Maintenance & Facilities Manager and the Maintenance Technicians, ensuring that all equipment and systems operate ... the maintenance team. This position reports to the Maintenance & Facilities Manager . Duties & Responsibilities + Lead and Supervise: Direct, mentor, and support… more
- Bristol Myers Squibb (Devens, MA)
- …complies with company policies, EHS safety procedures, and regulatory requirements ( FDA , OSHA, EPA). + Collaborates with multidisciplinary teams to support facility ... documents, schematics, and regulatory guidelines. + Familiarity with GMP, FDA , and other regulatory requirements for environmental controls in manufacturing.… more
- North Coast Seafoods (New Bedford, MA)
- …department's requirements are met. This position will report to a Production Manager . DUTIES AND RESPONSIBILITIES + Assist with managing the processing of products ... of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer… more
- Fresenius Medical Center (Lawrence, MA)
- …and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk ... external personnel in own area of expertise. . May escalate issues to supervisor/ manager for resolution, as deemed necessary. . Reviews and complies with the Code… more
- Beth Israel Lahey Health (Burlington, MA)
- …aspects of clinical trials research adhering to Research SOPs, GCP compliance and FDA regulations. 2) Functions as a mentor, resource and educator for clinical ... computer systems, including web based applications; Working knowledge of medical terminology, FDA , OHRP and GCP regulations and medical practice protocols; In the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …for Human Factors in Medical Device and healthcare regulations including the FDA 2016 Guidance, 'Applying Human Factors and Usability Engineering to Medical Devices ... Industry and Food and Drug Administration Staff ', the FDA 2022 Guidance, 'Content of Human Factors Information in...ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.**… more
- Bristol Myers Squibb (Devens, MA)
- …cryogenic storage (LN2) is preferred + Experience with health authorities (ie, FDA ) for audit support + Experience and familiarity with electronic systems including ... and in a timely manner to team and to manager as needed + Familiarity working in operational suites...+ US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to… more