- Sanofi Group (Cambridge, MA)
- …Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA) + Good knowledge of medical device regulations and international standards, eg: ISO 13485, 21 ... more
- US Tech Solutions (San Bruno, CA)
- …knowledge of Quality Concepts (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, ... more
- Abbott (Alameda, CA)
- …+ Advanced level degree + Experience with FDA, ANVISA, TGA, NMPA, EU and other international medical device / drugs / pharma regulations and submissions. + ... more
- AbbVie (Irvine, CA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... more
- AbbVie (Pleasanton, CA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... more
- J&J Family of Companies (Santa Clara, CA)
- …a PMA/PMAs (US Class III), IDE (US Class II/III), 510K (US Class III), other international medical device applications or other technical writing needs as ... more
- Olympus Corporation of the Americas (Center Valley, PA)
- …98/282 Canadian Medical Device Regulations, ISO 13485, and any other medical device industry international standards a plus. + Formal education ... more
- Terumo Medical Corporation (Somerset, NJ)
- …and conducting audits in operations, systems and other areas pertinent to the medical device industry preferred + International exposure most desirable ... more
- Abbott (Plymouth, MN)
- …+ Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements ... more
- Abbott (Plymouth, MN)
- …+ Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements ... more
- Abbott (Sylmar, CA)
- …+ Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements ... more
- Globus Medical, Inc. (Limerick, PA)
- …and procedures. Lead and enforce regulatory compliance with US FDA, State, OSHA and international medical device regulations and ISO 13485 quality system ... more
- Abbott (Plymouth, MN)
- …to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements ... more
- Fresenius Medical Center (Waltham, MA)
- …of the development and change processes. + Understands and interprets US and international medical device regulatory requirements; provides guidance on ... more
- Fresenius Medical Center (Raleigh, NC)
- …critical issues and broad design matters. + Understands and interprets US and international medical device regulatory requirements, provides guidance on ... more
- Amgen (Washington, DC)
- …+ 6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations + 8 plus years ... more
- Globus Medical, Inc. (UT)
- …with all company policies & procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system ... more
- Integra LifeSciences (Braintree, MA)
- …teams, marketing teams, quality teams). + Strong working knowledge of domestic and/or international medical device regulations including 510k, PMA, PMA ... more
- Abbott (Pleasanton, CA)
- …PMA supplements and US device regulations, or with EU and other international medical device regulations and submissions. + Must be familiar ... more
- Abbott (Pleasanton, CA)
- …PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions. + Ability to work ... more
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