- Hologic (Marlborough, MA)
- …and requirements traceability. + Familiarity with Good Laboratory Practices and global regulatory requirements for medical devices . + Proficiency in ... in ensuring the safety, reliability, and compliance of life-changing medical devices ? At Hologic, we are seeking...a subject matter expert, you will partner with R&D, Regulatory Affairs , and Manufacturing Engineering teams to… more
- Kelly Services (Raynham, MA)
- …in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common ... The CER Technical Writer must have experience within the medical device industry and knowledge of clinical...Directors, Post Market Surveillance, Design Quality Engineers, R&D, Clinical Affairs and Regulatory Affairs relating… more
- Astrix Technology (Boston, MA)
- …Work closely with internal teams such as Clinical Development, Regulatory Affairs , and Commercial to provide medical insights that inform strategic ... medical affairs role within the pharmaceutical, biotechnology, or medical device industry. + Scientific Expertise: Deep understanding of therapeutic… more
- Philips (Cambridge, MA)
- …the right fit if:** + You have a minimum of 15+ years' combined experience in Medical Device Clinical Research and Medical Device development within FDA ... Japan and China. + You have a detailed understanding of Clinical & Medical Affairs , leveraging expertise to propose innovative ideas, providing meaningful input… more
- Medtronic (Boston, MA)
- …prioritization. * Collaborate with Verification & Validation, Systems Engineering, and Regulatory Affairs to ensure appropriate test coverage and documentation. ... + Knowledge in product development, project management, and commercialization in the medical device industry + Strong communication and teamwork skills; must… more
- Hologic (Marlborough, MA)
- …leading major US and global clinical trials across multiple phases of medical device development. You'll ensure studies are executed on-time, on-budget, ... the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs , Program Management, Legal, Marketing, and Operations to… more
- Edwards Lifesciences (Andover, MA)
- …surgery or interventional cardiology are strongly preferred; candidates with other relevant medical device clinical sales support experience will be considered + ... Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. After extensive… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …provide innovative technologies that make a meaningful difference in people's lives. Our medical devices , software and related services are used worldwide to ... in product development (hardware or software) + Previous experience in supporting medical regulatory filings Required/Preferred Education and Experience + PhD in… more
- ConvaTec (Lexington, MA)
- …to 10 years of clinical trial management experience in conducting and leading global medical device clinical trials, preferably with a sponsor company. + Solid ... full-time Convatec CSMs). **Principal Contacts & Purpose of Contact** Internal - Medical Affairs , Clinical Operations (Study Management, Site Management, Data… more
- Takeda Pharmaceuticals (Boston, MA)
- …Takeda Oncology including Translational Medicine, Clinical Sciences, Global Regulatory Affairs , the Oncology Business Unit (Commercial and Medical Affairs ... and external diagnostic partners, and supporting health authority meetings and regulatory submissions (PMAs etc). This role will partner closely with key… more
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