- Chemours (Frankfort, KY)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- Cardinal Health (Phoenix, AZ)
- …Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance + Product Lifecycle Management + Initial ... consultants have provided expertise and guidance to help pharmaceutical, biotechnology and medical device companies get their products to market. Our … more
- Globus Medical, Inc. (Audubon, PA)
- …improvement, or manufacturing operations. + Strong understanding of medical device manufacturing, regulatory compliance , and quality assurance ... accuracy and resolving outstanding lot inspections. + Work with Regulatory teams (US and international) to ensure compliance...and fast-paced team dedicated to innovation and efficiency in medical device development. + Make a meaningful… more
- Cognizant (Chicago, IL)
- …discovery, Global Pharmaceutical market and industry, including BioTech, Medical Device , Traditional Rx, enabling technologies and regulatory / compliance ... **Experience Partner - Life Sciences (Pharma / BioTech / Medical Device )** **Associate Director - Chicago/Midwest Remote** **Who we are:** We are Cognizant… more
- Hologic (Marlborough, MA)
- …we'd love to hear from you! **Knowledge** + Deep understanding of global medical device regulatory frameworks and Quality Systems Management requirements. ... device industry? Hologic is seeking a **Senior Regulatory Compliance Specialist** to lead the charge...+ A minimum of 5 years of experience in Medical Device Regulatory Affairs, with… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +...detail with planning, time management and organizational skills + Regulatory compliance competency including Quality Systems +… more
- Sanofi Group (Cambridge, MA)
- …GRA Device representative in project/product teams + Develop innovative and sustainable medical device regulatory strategies + Provide regulatory ... device regulatory activities associated with Sanofi's combination product and medical device portfolio in the Specialty Care R&D and commercial product… more
- AbbVie (Irvine, CA)
- …works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and ... influence, and provide strategic advice. Additional Responsibilities Include: + Prepares device regulatory product strategies. Prepares and manages regulatory… more
- Wolters Kluwer (Chicago, IL)
- …the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP. Must have EU MDR and FDA ... on-market medical devices including Software as a Medical Device (SaMD) within the Health Division...subject matter expert. + Assure integration and support of device regulations and compliance with company policies… more
- Organon & Co. (Jersey City, NJ)
- …Activities will include developing, documenting, and review of documentation to ensure compliance with applicable Medical Device Regulations and internal ... Organon requirements. Sr. Quality Engineer ( Medical Device /Combo Products) is responsible for program...clinical supply, development, and design transfer qualification. + Ensure compliance with regulatory and Organon requirements. Evaluate… more
- Merck (West Point, PA)
- …launch in alignment with the company's business goals, and quality and regulatory compliance . **Essential Duties and Responsibilities:** **Program Leadership and ... needs. + Build strategic partnerships with manufacturing sites and partner groups + Regulatory Compliance and Quality Assurance: + Ensure that all activities are… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... mindset and drives a culture of continuous improvement in compliance with Sanofi's behavioral and ethical standards. This critical...regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of AbbVie's External and ... Product Quality Assurance group and reports to the Senior Manager, Medical Device External Quality. The role will be based out of Lake County, IL site. This role… more
- Henry Ford Health System (Detroit, MI)
- + GENERAL SUMMARY: Reporting to the Director of Medical Device and Emerging Technology Security, the Manager of IoT and Medical Device Security leads and ... and security best practices. The Manager of IoT and Medical Device Security is responsible for developing,...between security controls and clinical operations while maintaining strict regulatory compliance and enabling optimal patient care… more
- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** ** Device Clinical Strategy & Risk… more
- Merck (Rahway, NJ)
- …Making, Dosage Forms, GMP Compliance , Inspection Readiness, Management Process, Medical Device Management, Medical Devices, Operational Excellence, ... **Job Description** **Raw Materials & Medical Device Director, Small Molecule Analytical Research & Development** The Small Molecule Analytical Research and… more
- Integra LifeSciences (Plainsboro, NJ)
- …and set new standards of care. The **Sr.** **Quality Engineer - Medical Device / Pharma** will provide Plant Quality compliance support for the following ... that ensure that the development, manufacture and distribution of medical products is in compliance with corporate... Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory … more
- Sanofi Group (Cambridge, MA)
- …sooner than ever before. Our team has released an FDA certified class II medical device titration application. We are gearing up for other software applications ... You will be responsible for the quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring that they meet the highest standards of… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …you will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and cross-functional collaboration with ... development lifecycle of an off the shelf, or an internally designed platform medical device delivery system. + Defines detailed product requirements and… more
- Hologic (Marlborough, MA)
- Medical Device Reporting Specialist Marlborough, MA, United States We are seeking a detail-oriented and proactive Medical Device Reporting Specialist to ... considerations for treatment **Experience:** + 2-5 years progressive quality experience in Medical Device or related Industry. + Bachelor's Degree in Medicine,… more
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