- Meta (New York, NY)
- …**Minimum Qualifications:** Minimum Qualifications: 8. 7+ years of industry experience in medical device regulatory affairs or related industry 9. ... commercialized in the smart wearables and software as a medical device direct to consumer space. You... landscapes and driving successful product registrations. **Required Skills:** Medical Devices , Regulatory Affairs Lead… more
- Wolters Kluwer (New York, NY)
- …portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important ... activities, including verification and validation. + Lead resolution of quality issues with on-market device software; drive... regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP.… more
- Meta (New York, NY)
- …scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. Experience ... a regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …development lifecycle of an off the shelf, or an internally designed platform medical device delivery system. + Defines detailed product requirements and ... History File (DHF) is developed and ensures to meet regulatory and quality requirements (21 CFR 820.30)...combination of education and experience Previous experience in combination product/ medical device development or similar area is… more
- LSI Solutions (Victor, NY)
- …of experience working as a Regulatory Coordinator at a medical device company operating within a Quality Management System (QMS) certified to ISO 13485. ... govern the design, development, manufacturing, and distribution of our medical devices . REPORTS TO: REGULATORY ... Regulatory Coordinator at a medical device company operating within a Quality Management… more
- Chemours (Albany, NY)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- TD Bank (New York, NY)
- …and/or economic developments to support business needs and publish high quality research reports/presentations aligned to industries and various markets. Also ... reports, quarterly reporting initiatives, and marketing packages) + Publishes high quality , comprehensive analysis and research on industry sectors and companies… more
- Grifols Shared Services North America, Inc (Manhattan, NY)
- … submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams ... regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides … more
- Momentive Performance Materials Inc. (Niskayuna, NY)
- …legal regulatory questions and risk management in regulated applications, including medical devices , cosmetics, and food contact materials. + Assist in the ... Job Title: Senior Counsel - Regulatory & EHS Summary:In this highly visible and...closely with executives and staff within the EHS, Manufacturing, Quality , and Product Stewardship organizations, as well as the… more
- FREEMAN (New York, NY)
- …7-10 years of experience with product development in a regulated industry (eg, medical devices , aerospace). + Knowledge of lean product development principles. + ... Development Engineer to lead the development of innovative products that meet regulatory requirements and ensure customer safety. The ideal candidate will have a… more
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