- Dana-Farber Cancer Institute (Boston, MA)
- …samples are tested in the same manner as patient specimens. + Follow regulations ( FDA , CLIA, HIPAA, OSHA, state), standards (FACT, JC) and safety guidelines. + If ... applicable, answer questions from clinicians or other lab personnel. + Maintain complete records of all testing performed. + Maintain general clean and organized appearance of the department. + Ensure reagents/test kits have received dates, expiration dates,… more
- Veterans Inc. (Worcester, MA)
- …for safekeeping of all medication stock and the records required by the DEA, FDA , and Board of Pharmacy. + Collects and processes urine specimens as needed, manage ... test results as ordered by the Medical Director and ensures the completion of all forms involved in these procedures. + Provide patient education on health-related issues individually and in a group environment. + Attends and participates in all meetings as… more
- Takeda Pharmaceuticals (Boston, MA)
- …Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA , EU, MHRA, PMDA and ICH. + Experience must include successful ... development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations and remediation activities on a global level. + Experience in managing complex organizational compliance issues and in… more
- Abbott (Westford, MA)
- …requirements + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... and task assignments. Maintains positive and cooperative communications an collaboration with all levels of employees, customers, contractors, and vendors + Performs other related duties and responsibilities, on occasion, as assigned **Required… more
- Charles River Laboratories (Shrewsbury, MA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more
- Nitto Denko Corp. (Milford, MA)
- …and associated GMP documentation to ensure compliance with applicable regulatory standards ( FDA , EMA, ICH). This role serves as a Subject Matter Expert (SME) ... for Change Management processes across multiple sites (Milford, Irvine, and Cincinnati), and requires hands-on knowledge of Veeva and TrackWise system integration). Key Responsibilities: + Perform QA review and approval of Change Control Requests (CCRs) and… more
- Medtronic (Boston, MA)
- …Claims Act, HIPAA, state data privacy and security laws, software licensing, FDA law, IP and other legal risk areas governing data-enabled healthcare technology ... and AI commercial transactions. + Develop, review, or implement company-wide and/or functionally specific training programs for the areas described above. + Monitor evolving regulatory standards impacting commercial transactions of data-enabled healthcare… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and/or Med device or other device-related experience + Demonstrated expertise in applying FDA design control requirements (21 CFR ) as applied to medical device ... software and medical device regulation (IEC-62304) **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking &… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …develop an understanding of Institute policies and federal regulations (eg IRB, HIPAA, FDA , HSRP) and apply those frameworks into contracting. + Ability to identify ... issues and propose resolutions; creatively and actively solve problems + Must possess ability to thrive in a busy, high-volume, and deadline driven work team environment that requires coordination of multiple activities and the judgment and flexibility to… more
- Medtronic (Billerica, MA)
- …biotech, or pharmaceutical setting. + Familiarity with GMP, ISO, or FDA -regulated environments. + Working knowledge of building systems (HVAC, electrical, plumbing) ... and facility safety standards. + Proven experience managing contractors, budgets, and vendor relationships. + Strong leadership and interpersonal skills with a collaborative mindset. + Certified Facility Manager (CFM), LEED Accreditation, or equivalent… more