The QA/RA Administrator is responsible for reviewing and updating Quality Management System to align with current regulatory standards and guidance documents applicable to IVD/Medical Device (FDA 21 CFR 820, ISO13485: current, MDSAP, IVDR, etc.) conducting internal quality audits, supplier audits, corrective and preventive actions, complaint handling and non-conforming material process.
Regulatory Affairs Jobs
Regulatory Affairs Specialist Location: Miami Lakes, Florida, United States Requisition #: 19000ALZ Post Date: 14 hours ago **REGULATORY AFFAIRS SPECIALIST** Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.These opportunities stretch across all Medtronic Business Units, Product Groups […]
Sr Regulatory Affairs Specialist Location: Miami Lakes, Florida, United States Requisition #: 19000A5D Post Date: 14 hours ago **SENIOR REGULATORY AFFAIRS SPECIALIST** In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives […]
Senior Regulatory Affairs Specialist Location: Mounds View, Minnesota, United States Requisition #: 1900099T Post Date: 14 hours ago **SENIOR REGULATORY AFFAIRS SPECIALIST** The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions […]
Manufacturing Engineer – Senior Location: Brooklyn Center, Minnesota, United States Requisition #: 190007UH Post Date: 11 hours ago Engineers create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. The Senior Manufacturing Engineer is responsible for the evaluation, analysis, and […]
**Product Manager, Upstream Marketing, Transcatheter Heart Valves (THV)** **The Global Product Manager, Upstream Marketing, THV is responsible for developing and implementing new product planning and upstream marketing strategies for Edwards expandable access, and congenital pulmonic portfolios.** **This position will advance the Edwards transcatheter heart valve (THV) portfolio by managing upstream portfolio planning activities, analyzing market […]
1. Prepare and review product registration tasks covering the new product registration, progress reports, supplements, amendment, periodic reports and the renewal registration. 2. Support and coordinate with other functions to fulfill company’s regulatory tasks mandated by other existing local healthcare regulations, such as the completion of the device registration and tracking monthly reports, the device […]
Do you want to be part of an international, innovative, world-class pharmaceutical company? Of an organization committed to putting patients first? Pfizer has always evolved with the changing needs of the people who rely on us to create a healthier world For our Regulatory team in Capelle aan den Ijssel, we are looking for a […]
The Senior Regulatory Associate is mainly responsible for regulatory affairs support related to new product, line extension and lifecycle management within the country. To interface with other function lead (e.g. GCMC, GSCPM, HLM, HSM/SOS, PGS, Commercial, Medical, etc) to ensure collaborative connectivity with these key stakeholders, and a more focused regional RA approach to supporting […]
**Are you looking for a career that matters?** We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with […]
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