- Fujifilm (Boston, MA)
- …the business, to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- AbbVie (Worcester, MA)
- …the qualification and validation of analytical methods in accordance with ICH, FDA , and USP guidelines, ensuring methods are suitable for late-phase development and ... and regulatory guidelines. + Experience collaborating with the process development, quality control, and regulatory affairs teams to align analytical strategies with… more
- Eliassen Group (Boston, MA)
- …strengthen development efficiency * You'll interface with software test to ensure high quality product * You will develop automated unit and integration tests * ... applicable. BIG PLUS: Bluetooth experience & Any industry experience that has FDA requirements OR enterprise level company experience and documentation. There will… more
- Sanofi Group (Cambridge, MA)
- …and company activities. + Assists in ensuring product support relationships with FDA are established and maintained. + Provides input into the global organization ... family, with a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral… more
- Charles River Laboratories (Worcester, MA)
- …the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of ... 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
- Charles River Laboratories (Shrewsbury, MA)
- …the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of ... 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)
- …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
- Chewy (Boston, MA)
- …a key role in identifying and implementing opportunities to improve delivery quality and reduce packaging and operational costs through data-driven decision making. ... Preventive Controls Qualified Individual (PCQI) training. + Working knowledge of FDA regulations, including 21 CFR Part 507.27 (Current Good Manufacturing Practice… more
- Beth Israel Lahey Health (Burlington, MA)
- …+ Pleural disease management + Bronchoscopic Lung Volume Reduction (BLVR) using FDA -approved technologies + **Lead and expand the BLVR program** , overseeing patient ... **Academic & Research Engagement** + Engage in **clinical research** and quality improvement initiatives related to interventional pulmonary procedures and BLVR. +… more
- Sumitomo Pharma (Cambridge, MA)
- …specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data presentations and TFLs. ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more