- Mentor Technical Group (Boston, MA)
- …the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, ... PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Responsibilities: + Maintains a daily Log of metrics gathered, for example,… more
- Abbott (Burlington, MA)
- …of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... On** + As part of the Global Design Quality Department, provide oversight of R&D design control deliverables for development of medical product software (Cloud… more
- Abbott (Burlington, MA)
- …or a related field. + Knowledge of regulations, standards, and guidance affecting medical software and non- medical device software development. + Expert ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Medtronic (Newton, MA)
- …Ablation System** The Affera Mapping and Ablation System is an innovative medical technology designed to treat patients with cardiac arrhythmias. The system involves ... to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference...to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference… more
- J&J Family of Companies (Danvers, MA)
- …Interventional Cardiology to be located in Danvers, MA. The MSO role is to provide medical safety stewardship for Medical Device (MD) products. Although a ... with J&J Heart Recovery/Abiomed Impella Pumps. + Background in risk evaluation, medical device /pharma industry, and clinical research. + Knowledge of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …product development, launches, and lifecycle management. You will work closely with R&D teams to ensure the development and seamless technology transfer of ... Sciences and/or Operating Units, including: + Combination products and device manufacturing process development, characterization, and optimization-including fill/finish, assembly,… more
- Medtronic (Boston, MA)
- …plays a critical role in ensuring the security of Medtronic Surgical Operating Unit medical device solutions. Reporting to the Director of Product Security, this ... impact by exploring a career with the world's leading Medical Device company, striving "to alleviate pain,...to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference… more
- Sanofi Group (Framingham, MA)
- …framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. Our ... people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a critical strategic partner within Sanofi's regulatory… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and digital health solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies aligned with the ... + Develop and maintain SOPs, compliance frameworks, and internal guidance tailored to non- medical device digital health initiatives. + Design and deliver regular… more
- J&J Family of Companies (Danvers, MA)
- …dual-role position that combines field-based clinical research engagement, technical expertise in medical device support, and on call, bedside clinical support. ... and feedback ("Voice of Investigator") to Abiomed cross-functional partners such as R&D , medical affairs, marketing, sales, and education. JOB DUTIES +… more