- Marmon Holdings, Inc. (Addison, TX)
- …Job Scope The Regulatory Affairs (RA) Specialist is responsible for ensuring regulatory compliance for medical devices in accordance with applicable ... The Regulatory Affairs Specialist will assist in regulatory submissions, listings, and registration of medical ...and assists in determining impact and appropriate action. Ensures regulatory compliance of products and processes through… more
- Abbott (Pleasanton, CA)
- …in related field Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance /Affairs experience in medical device manufacturing or ... understand quality system requirements and how they impact product quality and regulatory compliance . Represents the division within Abbott through Corporate… more
- Integra LifeSciences (Princeton, NJ)
- …and execute plans. Deep knowledge of global sourcing, contract manufacturing, and regulatory compliance in medical devices. Strong leadership, negotiation, ... and a thorough evaluation of financial stability, operational capabilities and compliance history. Collaborate closely with R&D, Quality, Regulatory , Legal,… more
- Sharp HealthCare (La Mesa, CA)
- …sets. The RN CM has accountability for maintaining compliance contractual and regulatory compliance with medical groups as applicable and the hospital. ... position requires the ability to combine clinical/quality considerations with regulatory /financial/utilization review demands to assure patients are receiving care… more
- Gila River Health Care Corp (Sacaton, AZ)
- …with organizational policy in order to ensure patient and physician safety and regulatory compliance . Conducts tests of medical instruments to check ... instructions for use in order to ensure patient safety and regulatory compliance . Identifies medical instruments, tests for proper functionality, and… more
- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- Merck & Co. (Rahway, NJ)
- …Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling, ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... offer a comprehensive package of benefits.- Available benefits include medical , dental, vision healthcare and other insurance benefits (for...Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in… more
- Ripple (San Francisco, CA)
- …join us, and build real world value. THE WORK: Ripple is growing its Regulatory Compliance team and is seeking an experienced Senior Analyst to join ... presents an outstanding opportunity to support the day-to-day operations of our Global Regulatory Compliance Program. Ripple's Regulatory Compliance team… more
- Amazon (Reading, MA)
- …rewarding, fulfilling and fun. Amazon Robotics is seeking a safety focused Regulatory Compliance Engineer with experience fielding industrial machinery with an ... lead new and existing product development work related to regulatory compliance and safety. The ideal candidate...that generally apply to regular, full-time employees include: 1. Medical , Dental, and Vision Coverage 2. Maternity and Parental… more
- Citigroup, Inc. (Irving, TX)
- …and monitoring of compliance related issues. Reviewing materials to ensure compliance with various regulatory and legal requirements and to ensure ... risks are appropriately identified and addressed. Investigating and responding to compliance risk issues. Investigating regulatory inquiries, preparing required… more
- Kyowa Kirin North America (Princeton, NJ)
- …and communications with OPDP, and any supporting documentation *Provide relevant regulatory compliance training to staff and cross-functional partners from ... North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Regulatory Affairs, Advertising and Promotion Compliance will independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... years of experience in GxP-regulated IT system implementation, validation, and compliance in pharma/biotech/ medical device industry - Required 4+ years… more
- Abbott (Maple Grove, MN)
- …support Ad and Promotional Material - Regulatory Review EU and US medical device compliance Project management skills - organize and host meetings Quality ... Services (GRS) function managing projects related to harmonized regulatory activities in the Abbott's medical device...RA QA Specialist is to combine the knowledge of Regulatory , Quality and Compliance to lead and… more
- Intertek (Cortland, NY)
- Job Description Engineer - HVAC Safety, Regulatory Compliance , Cortland, NY Intertek, a leading provider of quality and safety solutions to many of the top ... recognized brands and companies is actively looking for Engineer - HVAC Safety, Regulatory Compliance to join our Electrical team in Cortland, NY . This is a… more
- Bausch Health (Bothell, WA)
- …guidance, and national/international standards. Work together with Bausch Health Group PRC regulatory lead, ensuring regulatory compliance for Solta ... Manager, Regulatory Affairs Medical Device-Aesthetics (Bothell, WA) 1 of 2 Job Location: Bothell, Washington, USA Job Requisition ID: 13600 Join our global… more
- Community Health Systems (Longview, TX)
- …and organizational skills to maintain accurate records and ensure regulatory compliance . Licenses and Certifications MLT - Medical Technician - ASCP required ... tests while adhering to strict quality control standards, laboratory protocols, and regulatory guidelines. The Medical Lab Technician is also tasked with… more
- Abbott (Santa Clara, CA)
- …communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance . Premarket: Assess the acceptability of quality, ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Globus Medical (Audubon, PA)
- …needed for IDE and PMA reporting Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes Performs routine maintenance ... Code, MedTech Code, and all other company policies. Ensures Compliance with applicable governmental laws, rules, and regulations, both...is a plus Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,… more
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