- J&J Family of Companies (Danvers, MA)
- …mechanical, and systems engineers. + Collaborate closely with software, systems, quality , regulatory , manufacturing, and clinical teams. **Product Development** ... portfolio and platform investments. + Represent Abiomed in audits, regulatory discussions, and supplier/partner engagements. **Qualifications** _Required:_ + Bachelor's… more
- Pfizer (Boston, MA)
- …Injectables experience, including buy-and-bill strategies and demonstrated knowledge of: Regulatory pathways ( FDA , EMA, Health Canada) and interchangeability ... requirements. + Manufacturing and quality standards for biologics, amd generic sterile injectables including...disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of… more
- Sanofi Group (Cambridge, MA)
- …competitive edge. + Collaborate with cross-functional teams to prepare for regulatory inspections and internal audits, ensuring compliance and addressing findings ... + 5+ years of experience in design controls and FDA / ISO 13485 / IEC 62304 compliant software.../ ISO 13485 / IEC 62304 compliant software development, regulatory submissions, and launch. + Having knowledge of EHR… more
- Integra LifeSciences (Braintree, MA)
- …to resolve environmental control issues. + Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of ... management systems (BMS) and automated environmental controls. + Knowledge of regulatory requirements in the medical device or pharmaceutical industry. + Experience… more
- Sanofi Group (Cambridge, MA)
- …the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions ... development strategies for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project… more
- AbbVie (Worcester, MA)
- …SCADA, and Data Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions ... rules, and regulations. + Collaborate with cross-functional teams including Operations, Quality , IT and Maintenance. + Manage and supports control system including… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... is a senior leader within the Learning Center of Excellence under Global Quality . This role is responsible for developing and executing global training strategies… more
- ThermoFisher Scientific (Tewksbury, MA)
- …guidelines of product development and mechanical engineering while satisfying applicable regulatory and quality requirements. + Incorporate principles of Build ... + Familiarity with root cause analysis, DOE, CpK, and other quality and process measurement and analysis techniques. + Demonstratable understanding of… more
- Charles River Laboratories (Wilmington, MA)
- …as required. + Share customer problems/concerns with all appropriate departments for quality resolution. + Perform all other related duties as assigned. + Prepare ... needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements,… more
- Medtronic (Newton, MA)
- …Appium, Katalon, Squish etc.) + Ability to work with QA to ensure testing meets Quality and Regulatory needs. + Ability to manage, track and upgrade multiple ... Ablation System team. This role is essential in supporting the testing and quality assurance processes to ensure the reliability and performance of our advanced… more