- Fujifilm (Albany, NY)
- …Positive customer surveys, documentation accuracy and consistency, timely case and project completion, and finishing the assigned trainings are standard expectations ... level of success with yearly goals provided by your manager and metrics defined on a team level. +...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …and policies to ensure assigned areas are operating to current FDA and International Regulatory Body requirements. Available Work Schedules: + Monday-Friday, ... and systems and contribute to the continuous improvement culture. + Maintain project timelines associated with initiatives to support the evolving business. This… more
- Regeneron Pharmaceuticals (Troy, NY)
- …role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams and development partners, and leading activities with the ... is a plus. + Experience in dealings with the FDA and other regulatory authorities. + Experience managing and...performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and… more
- Excellus BlueCross BlueShield (Rochester, NY)
- …associations, the BlueCross BlueShield Association, the Food and Drug Administration ( FDA ), and Centers for Medicare and Medicaid Services (CMS). Provides routine ... investigations, compliance and regulatory issues and exercises decision-making in project work groups. + Assesses potential non-compliance vulnerabilities, identifies… more
- Nissha Medical Technologies (Buffalo, NY)
- …interest in manufacturing. You will focus on becoming familiar with ISO 13485 and FDA requirements that must be met for NMT's manufactured medical devices. As a part ... improve by accepting candid feedback Knowledge, Skills, and Abilities * Excellent project management skills * Strong problem solving skills to make informed… more
- Parexel (Albany, NY)
- …(SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for ... (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study...of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be fluent… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …audit-ready and aligns with operational priorities. While not a formal people manager , the Lead provides informal leadership, technical guidance, and mentorship to ... workflows-enabling the Metrology Engineer to focus on technical strategy and project support. Duties & Responsibilities + Review and analyze maintenance and… more
- Cardinal Health (Albany, NY)
- …(General Data Protection Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV (Computer System Validation), DSCSA(Drug ... and implement control framework across it + Hands-on experience with GRC platforms, project management tools, and service management systems, with a focus on scaling… more
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