- 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 ... we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science...development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... and procedures. + Effective communication within FUJIFILM IVD organization of sales, quality and compliance issues. + Utilization of the IVD reporting systems for… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... rides within field regions with direct reports to evaluate regulatory compliance and abilities to deliver 'best in class'...Ability to lead region in delivery of consistent and quality education to hospitals and healthcare professionals + Ability… more
- Charles River Laboratories (Shrewsbury, MA)
- …+ Other: Demonstrated analytical and problem solving capabilities. Understanding of regulatory requirements of study types assigned, as well as Testing Facility ... we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science...development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …issues, initiatives, and projects. Assures compliance with accrediting agency and regulatory requirements. Establishes and monitors performance and quality ... Supply Chain Management to ensure surgical implants are Federal Drug Administration ( FDA ) approved. Completes a variety of non-supervisory ad hoc projects and… 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 ... we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science...development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories… more
- Medtronic (Boston, MA)
- …and other legal and compliance professionals, as needed, to deliver the highest quality practical and strategic advice to sales, finance, and other stakeholders to ... Claims Act, HIPAA, state data privacy and security laws, software licensing, FDA law, IP and other legal risk areas governing data-enabled healthcare technology… more
- J&J Family of Companies (Danvers, MA)
- …documentation including test protocols, reports, and engineering rationales to support both quality and regulatory documentation. + Develop Test Methods and ... 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)
- …and mentor a team of verification engineers, promoting a culture of quality , collaboration, and continuous improvement. . Test Development: Design and implement both ... with relevant medical device regulations such as ISO 13485, IEC 62304, and FDA guidelines. . Defect Management: Lead root cause analysis and resolution of defects,… more
- AbbVie (Worcester, MA)
- …Complete other special projects and assignments as required + Comply with all regulatory , corporate, and site quality system procedures, especially safety and ... renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA /GMP regulated environment. The engineer will work in a multi-disciplinary team… more