- Lilly (Indianapolis, IN)
- …and practical experience with medical device / combination product quality & regulatory requirements, including GMP/CFR, EU MDR, ISO and IEC requirements ... will provide leadership for Commercialization Global Program Managers (GPM's) who lead medical device and drug/ device combination product commercialization… more
- Medtronic (Santa Ana, CA)
- …are evident on your resume._ + Requires a Bachelor's Degree + Minimum of 7 years of medical device quality , regulatory or engineering experience, + Or an ... advanced degree with a minimum of 5 years of medical device quality , regulatory or engineering experience **Nice to Have** + Experience working in … more
- Edwards Lifesciences (Irvine, CA)
- …role will provide high- quality guidance and support to Edwards' leaders on medical device commercial, clinical, regulatory , quality and reimbursement ... legal guidance on the Company and TAVR business's commercial, regulatory , clinical and quality legal issues, this... guidance and support to Edwards' on healthcare and medical device regulatory matters, including… more
- Integra LifeSciences (Boston, MA)
- …work experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other cGMP ... to advance patient outcomes and set new standards of care. **SUMMARY** The Quality Control Technician II will be responsible for performing Quality Control… more
- Hologic (Marlborough, MA)
- …to hear from you! **Knowledge** + Deep understanding of global medical device regulatory frameworks and Quality Systems Management requirements. + ... + A minimum of 5 years of experience in Medical Device Regulatory Affairs, with...managing corrective and preventive actions (CAPAs), non-conformances (NCs), and Quality Plans. + History of contributing to cross-business unit… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... for CE Marking. The Senior Specialist ensures timely and high- quality execution of all regulatory deliverables. In...years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +… more
- Sanofi Group (Cambridge, MA)
- …GRA Device representative in project/product teams + Develop innovative and sustainable medical device regulatory strategies + Provide regulatory ... regulatory activities associated with Sanofi's combination product and medical device portfolio in the Specialty Care... quality , supply chain) and Global Business Units. Medical device technology is often exploring new… more
- Organon & Co. (Jersey City, NJ)
- …and review of documentation to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. Sr. Quality Engineer ( ... cGMP and quality issues related to pure medical devices and the device constituent of... regulatory agency inspections with focus on relevant device regulations and Quality system requirements. +… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of AbbVie's ... Assurance group and reports to the Senior Manager, Medical Device External Quality . The...internal stakeholders to ensure compliance with defined specifications and regulatory requirements. The position also supports Quality … more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Sr.** ** Quality Engineer - Medical Device / Pharma** will provide Plant ... Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory ...Experience: 6 to 8 years of experience in a Quality Assurance role for medical device… 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 ... a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important… more
- Sanofi Group (Cambridge, MA)
- …will be responsible for the quality assurance efforts for our Software as Medical Device (SaMD) products, ensuring that they meet the highest standards of ... and quality standards, providing metrics, and addressing quality and regulatory issues. + Author and...sciences. + 4+ years' experience in medical device product development (Design Control) focused on quality… more
- Globus Medical, Inc. (Audubon, PA)
- …improvement, or manufacturing operations. + Strong understanding of medical device manufacturing, regulatory compliance, and quality assurance ... Assurance** + Ensure all Globus products and processes meet regulatory and internal quality standards. + Review,...and fast-paced team dedicated to innovation and efficiency in medical device development. + Make a meaningful… more
- GRAIL (Washington, DC)
- …of working in IVD, medical device , or pharma industries in regulatory affairs/ quality roles with experience of regulatory submissions and safety. IVD ... needed, on IVD product registrations and audits. Supports US regulatory team and partners with Quality , and... device experience is preferred. + Experience with regulatory support and submissions in the UK and EU… more
- Astrix Technology (Fort Worth, TX)
- ** Quality Assurance Manager - Medical Device ** Quality Assurance Fort Worth, TX, US Pay Rate Low: 85000 | Pay Rate High: 90000 + Added - 04/06/2025 Apply ... possesses these top 3 skills:** + Medical Device /Pharmaceutical industry experience + 4+ Years of Quality...distribution practices. + Ensure ISO 13485 standards and company quality and regulatory requirements are being met.… more
- US Tech Solutions (San Bruno, CA)
- …align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification, ... (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory ... Manufacturing or Software as a Medical Device (SaMD). + Experience with Quality Management… more
- Pentax Medical (Redwood City, CA)
- … Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Medical Device Assembler- Catheter Why ... JOIN Us? We are an established medical device leader that is preparing for...attention to detail and work in accordance with all quality , regulatory and safety requirements It is… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... BS with 10 years regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory experience required. + At least… more
- Lilly (Indianapolis, IN)
- …14971, Canadian MDR, EU Medical device Directive, JPAL) + Regulatory inspection experience + Technical knowledge in Quality System elements, devices, ... for people around the world. The Associate Director- Quality - Indianapolis Device Manufacturing Device Quality Control Lab is primarily responsible… more
- Takeda Pharmaceuticals (Lexington, MA)
- …multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** ** Device ... liaison to Global Device Team, including engineering, regulatory affairs, quality , and commercial functions +...of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience +… more
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