- Philips (Murrysville, PA)
- …if:** + You've acquired a minimum of 10+ years' experience working in FDA regulated medical device quality environments, with a deep understanding of ISO ... Release Strategy & Execution:_** Will Partner with cross-functional teams ( Quality , Regulatory , Medical , Supply Chain,...13485 QMS, compliance, and regulatory requirements related to medical … more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …on a global basis and works closely with marketing, operations, manufacturing plants, quality , medical affairs, and regulatory affairs. Hybrid Work Schedule: ... may include: * Lead a cross-functional team, including R&D, Quality , Regulatory , Medical , and Manufacturing...six-sigma design and development background. * Has successfully launched medical device products from concept through launch.… more
- Takeda Pharmaceuticals (Boston, MA)
- …patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager) Plasma-Derived Therapies ... Global Device Sub team to ensure that regulatory device labeling requirements are met for...and/or high complexity products (including combination, Software as a Medical Device , and standalone medical … more
- Lilly (Indianapolis, IN)
- …application of existing and new standards, regulations, and guidance with regards to medical devices and device constituents of combination products within ... device regulations, CE marking support of new devices . This role also supports hosting of regulatory... devices . This role also supports hosting of regulatory inspections and performing quality system gap… more
- Kelly Services (Valencia, CA)
- …with business stakeholders within a cross-functional matrix environment. * 5+ years Class III Medical Device Company in Regulatory Affairs. * Experience with ... landscapes and ensuring compliance with all applicable regulations of active implantable medical devices . Your expertise will contribute to creating and… more
- Organon & Co. (Jersey City, NJ)
- …+ Participate on Organon teams supporting cGMP and quality issues related to pure medical devices and the device constituent of a combination product. + ... responsible for independent support of development and commercialization of Medical Devices including the device ... regulatory agency inspections with focus on relevant device regulations and Quality system requirements. +… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Medical Device Quality - Software will act as the ... medical devices including Software as a Medical Device (SaMD) and Software in a...IL and report directly into the Senior Manager of Medical Device Quality . + Leads… 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...external product quality assurance (EPQA) for commercial medical devices which are manufactured by third… more
- Pentax Medical (Montvale, NJ)
- …benefits program and generous Paid Time Off and Holiday policy. Want More INFO? The Medical Device , Senior Quality Engineer will lead and implement ... imaging devices and solutions to the global medical community. Position Opening: Senior Quality Engineer...root causes and effectively implement the remediations. Responsibilities of Medical Device , Senior Quality Engineer… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …and 8 years experience in Quality , Regulatory , or Operations of a Medical Device firm in a supervisory role. + Professional certification is an advantage ... 13485:2016 + Knowledge of laws, regulations, standards and guidelines governing the sale of medical devices in Canada, the United States and Europe. + Ability… more
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