- Meta (New York, NY)
- …the combination of AI with great form factors can do. We are seeking an experienced medical devices regulatory affairs professional to help us execute ... products with distribution into many worldwide markets. **Required Skills:** Medical Devices Regulatory Affairs...Medical Device Directive & European Union Medical Device Regulation, FDA regulatory … more
- Stryker (Mahwah, NJ)
- …3+ years of experience in an FDA regulated industry + 2+ years of experience in medical device regulatory affairs + Thorough understanding of FDA, ... Europe, and international medical device regulations + Experience drafting regulatory submissions... Affairs ) + Previous experience with Class II/III medical devices + Previous experience drafting 510(k)s… more
- Meta (New York, NY)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... 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
- Stryker (Mahwah, NJ)
- …of managerial/supervisory experience + Understanding of global medical device regulations including direct experience with regulatory submissions associated ... We are currently seeking a **Senior Manager, Regulatory Affairs ** to join our Joint...with US and EU Class II/III medical devices + Ability to lead a… 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 ... software launches and market expansions. **Post-Market Surveillance and Regulatory Affairs ** + Coordinate post-market activities including... regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP.… more
- Veterans Affairs, Veterans Health Administration (Montrose, NY)
- …various reports; and works in various environmental conditions. Regularly inspects the medical center to identify potential occupational health hazards and the need ... officials concerned with implementation and compliance of statutory and regulatory occupational health requirements. Conducts a full and comprehensive industrial… more
- Grifols Shared Services North America, Inc (Stamford, CT)
- …regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides ... staff + May have responsibility for maintaining a compliant medical device quality system for R&D and...years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the… more
- Stryker (Mahwah, NJ)
- …Evaluation documentation (eg, CERs, CEPs, SSCPs, PMCFPs, PMCFRs) to bring State of the Art medical devices to market. You will act as the subject matter expert ... an FDA or highly regulated industry required; preferably with medical devices . + A minimum of 2.... + A minimum of 2 years in a Regulatory Affairs role required. + Experience in… more
- Danaher Corporation (New York, NY)
- …adoption strategies + Regulatory Knowledge: In-depth understanding of IVD and medical device regulations with strong familiarity of IVD applications in ... Science Liaison (Sr. MSL) will plan and execute the local and regional Medical Affairs (MA) strategies which are aligned and complement the Global MA strategies.… more
- Stryker (Mahwah, NJ)
- …guidance to PD engineers and collaborating with cross-functional teams, including Marketing, Regulatory Affairs , Quality, and Operations. This role requires a ... end users (surgeons), to ensure the successful development of medical devices from inception to launch. **What...Qualificaitons_** + **Product & Industry Expertise** : Experience in medical device or regulated industries with exposure… more
- System One (Park Ridge, NJ)
- …directly impact product safety, regulatory success, and speed-to-market for critical medical devices and healthcare products. As a recognized authority, you ... + Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements… more
- Danaher Corporation (New York, NY)
- …Managers towards it; build and maintain strong relationships with R&D, Clinical & Regulatory Affairs , Marketing, Operations, and Quality + Own & improve Beckman ... lifecycle management within the Diagnostics industry or a related field (eg, Medical Device , Pharmaceuticals, Biotechnology, Life Sciences) and a deep knowledge… more
- Dow Jones (New York, NY)
- …and the businesses that run it, from the pharmaceutical makers and biotech, to medical devices , hospitals and pharmacy benefit managers.** This is a critical ... is now under assault from threatened tariffs, funding cuts and a shifting regulatory environment. And they own vast oceans of highly personal data that, combined… more