- 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 safety equipment. + If needed, participate in government or regulatory agency inspections. Minimum Education requirement: + Associate degree in chemical,… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …Supply Chain Management to ensure surgical implants are Federal Drug Administration ( FDA ) approved. Completes a variety of non-supervisory ad hoc projects and ... initiatives, and projects. Assures compliance with accrediting agency and regulatory requirements. Establishes and monitors performance and quality metrics. Revises… more
- Charles River Laboratories (Shrewsbury, MA)
- …with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… 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 ... training programs for the areas described above. + Monitor evolving regulatory standards impacting commercial transactions of data-enabled healthcare technology and… more
- Medtronic (Billerica, MA)
- …quality, and manufacturing teams to ensure compliance with safety, health, and regulatory requirements (OSHA, EPA, local codes). + Lead space planning, renovations, ... biotech, or pharmaceutical setting. + Familiarity with GMP, ISO, or FDA -regulated environments. + Working knowledge of building systems (HVAC, electrical, plumbing)… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …Windows environment. Familiar with MS Office, including Excel and Word. + Knowledge of FDA QSR required + Knowledge of USA and international regulatory Medical ... Device Reporting preferred. + Must be able to communicate verbally and in writing and work effectively within a multi-disciplined organization ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired… more
- Stantec (Burlington, MA)
- …related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in ... in conformity with specifications, design intent and client/user and regulatory requirements. Working under the guidance of Director of commissioning/validation,… more
- J&J Family of Companies (Danvers, MA)
- …protocols, reports, and engineering rationales to support both quality and regulatory documentation. + Develop Test Methods and understand requirements for ... of Medical Device Design Controls and Product Life cycle + Knowledge of FDA and EU MDR regulations + Ability to communicate ideas and information clearly,… more
- Capgemini (Burlington, MA)
- …with relevant medical device regulations such as ISO 13485, IEC 62304, and FDA guidelines. . Defect Management: Lead root cause analysis and resolution of defects, ... privacy in medical systems. . Familiarity with medical device standards and regulatory requirements. . Proficiency in scripting and test automation tools (eg,… more
- Teleflex (Chelmsford, MA)
- …GMPs and are auditable at all times. Assures compliance with GMP (ISO 13485, FDA 21 CFR 820, MDD 93/42EEC, and all applicable standards) * Lead discussion with ... Act in accordance with all relevant statutory requirements and/or other regulatory provisions, and other internal standards. **Education / Experience Requirements**… more