- Edwards Lifesciences (Boston, MA)
- …the Cordella PA Sensor is revolutionizing how heart failure is managed, improving quality of life while slashing hospital admissions and health care costs along the ... Our other star player? You! IHFM has achieved a significant milestone and received FDA approval for our Cordella PA Sensor. Join us as we commercialize this… more
- Medtronic (Boston, MA)
- …stakeholders for R&D, QA, Operations, functional COEs, regional Regulatory and Quality , and the Medtronic Enterprise Focuses on tactical, operational and strategic ... of similar complexity) program management and implementation Experience working with US FDA , EU Notified Bodies and/or other regulators during the review of… more
- Sanofi Group (Cambridge, MA)
- …the GPT are conducted in compliance with current regulations, laws, and guidance from FDA , EMeA, and CHMP, as well as with Sanofi's policies and procedures. **About ... 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
- Sumitomo Pharma (Boston, MA)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of… more
- Fujifilm (Boston, MA)
- …and procedures. + Effective communication within FUJIFILM IVD organization of sales, quality and compliance issues. + Utilization of the IVD reporting systems for ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... adversely and communicating these on a timely manner. + Guarantee top quality of services provided to client by reviewing work performed, documentation submitted,… more
- North Coast Seafoods (Boston, MA)
- …the following motions: bending, twisting, squatting and reaching . Exposure to FDA approved cleaning chemicals . Exposure to temperatures: <32 degrees Fahrenheit . ... health care coverage, vacation and 401(k) to all full-time benefit-eligible employees. Employees also have access to the highest quality seafood at cost. more
- Sanofi Group (Cambridge, MA)
- …the GPT are conducted in compliance with current regulations, laws, and guidance from FDA , EMeA, and CHMP, as well as with Sanofi's policies and procedures. **About ... 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
- 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 ... processes + Ability to lead region in delivery of consistent and quality education to hospitals and healthcare professionals + Ability to strategically develop… 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