- 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
- United Therapeutics (Albany, NY)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)**...experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of… more
- ThermoFisher Scientific (Rochester, NY)
- …least 2 years of experience in a regulated industry (pharmaceutical or medical device ). **Preferred Qualifications** + Familiarity with product stewardship, ... regulations (EU REACH, CA Prop 65, TSCA). + Understanding of pharmaceutical and medical device standards and regulations (USP, ISO 10993, ISO 13485, IVDR,… more
- Fujifilm (Albany, NY)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... The Senior Counsel, reporting to the Division General Counsel, Medical Devices , will be an experienced commercial...Counsel and senior business management on general legal and regulatory risks affecting the Medical Device… more
- Veterans Affairs, Veterans Health Administration (Syracuse, NY)
- …including, but not limited to, node to server failures. Adheres to VA Medical Device Cyber Security policies and procedures in pre-procurement, during system ... card holder, as required. Investigates, remediates and documents Repairable Medical Device recalls and safety alerts issued...with leading and managing installation or upgrade projects for medical devices and systems. This includes but… more
- Veterans Affairs, Veterans Health Administration (Buffalo, NY)
- …include Decontamination, Sterile Preparation, Sterile Storage, Endoscope Reprocessing, and Reusable Medical Devices (RMD) reprocessing for the VHAWNY (Buffalo) ... The incumbent participates in the planning and facilitating of sterilization of reusable medical equipment for use throughout all clinical and patient care areas of… more
- Cardinal Health (Albany, NY)
- …**_Job Summary_** The Senior Regulatory Specialist, Data Management & Governance for Medical Devices plays a critical role in ensuring that Cardinal Health's ... **_What Regulatory Affairs contributes to Cardinal Health_**...assurance, or regulatory compliance role within the medical device or a highly regulated life… more
- Grifols Shared Services North America, Inc (Manhattan, NY)
- …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
- Danaher Corporation (New York, NY)
- … regulatory , market access, and post-market). You'll collaborate with clinical, regulatory /quality, R&D, medical affairs , IT/security, and our Operating ... and visualization tools. + Proven experience analyzing RWE/RWD (EHR, claims, registries, device logs) for clinical, regulatory , or market access impact. Travel,… more
- Philips (Latham, NY)
- …of experience in Medical /Clinical Affairs or equivalent in the medical device industry. Strong knowledge and experience working in the cardiovascular ... trends, and supports stakeholder awareness. + Ensures compliance with medical affairs activities, including Investigator Initiated Research...domain and with cardiovascular medical device products is required. Experience with… more
- Cordis (New York, NY)
- …key clinical and scientific insights to internal stakeholders-such as Clinical Development, Medical Affairs , and Commercial teams, helping shape strategy and ... and medical information between KOLs, other investigators and the company's Medical Affairs , Marketing and R&D groups. + Propose strategic solutions to… more
- Edwards Lifesciences (New York, NY)
- …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
- University of Rochester (Rochester, NY)
- …quality and regulatory compliance with investigational products for biologics and medical devices preferred. **KNOWLEDGE, SKILLS & ABILITIES** + Proven track ... + Relevant certifications such as American Society for Quality (ASQ), Certified Regulatory Affairs Certification (RAC), or Certified Quality Auditor (CQA) upon… more
- Otsuka America Pharmaceutical Inc. (Bronx, NY)
- …coordinating with other local Neuroscience Specialists and cross functional colleagues in Medical Affairs (MSLs) and Market Access (RAMs) under appropriate ... **Position Overview** This position requires a deep understanding of regulatory requirements, operational challenges, and the distinct clinical and...+ A minimum of 2 years of pharmaceutical or medical device sales experience. + Must reside… more
- WMCHealth (Valhalla, NY)
- …reimbursement requests at the conclusion of patient's participation in protocol + Regulatory Affairs : Responsible for preparing and submitting new research ... and as the operational liaison for other research organizations, funding agencies and regulatory bodies. + Assists in training PIs and other research staff on the… 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