- Abbott (Maple Grove, MN)
- …managing projects related to harmonized regulatory activities in the Abbott's medical device division. As an individual contributor, the function of a ... medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance,...- Regulatory Review + EU and US medical device compliance + Project management skills… more
- Cardinal Health (Mansfield, MA)
- …of the QA/QC department supporting Chemical Characterization of Medical Devices and Pharmaceutical Stability testing. + Provide Quality Assurance review ... perform laboratory testing to characterize the chemistries of our medical device products and stability testing for...pharmaceutical products of Cardinal Health. Under the umbrella of Quality , Regulatory & Medical Affairs… more
- Cardinal Health (Mansfield, MA)
- …for pharmaceutical products of Cardinal Health. Chemistry Services is a part of Quality , Regulatory & Medical Affairs (QRMA) Scientific Services. Under ... and data documentation. + Collaborate with cross-functional teams including Quality Assurance, and Regulatory Affairs and other...benefits and programs to support health and well-being. + Medical , dental and vision coverage + Paid time off… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices ...years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +… more
- Abbott (Alameda, CA)
- …5 years of experience in Quality Systems, Quality Assurance and/or Regulatory Affairs + Medical device industry or other regulated environment ... are in place to meet global regulatory requirements. Provide metrics on medical events to support management of product quality issues. **What You'll Work… more
- Bausch Health (Bothell, WA)
- … required + Must have a solid understanding of Change Management/Life Cycle Management of medical device products along with the impact of changes on US Canada ... written and communication skills. + Should have experience authoring complete 510(k) submissions, Medical Device license applications (Class II or above), EU MDR… 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
- 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 ... sciences. + 4+ years' experience in medical device product development (Design Control) focused on quality...Relevant experience in risk management for medical devices . + Good knowledge of Quality System… more
- Meta (Burlingame, CA)
- …combination of AI with great form factors can do. We are seeking an experienced medical devices regulatory affairs professional to help us execute ... products with distribution into many worldwide markets. **Required Skills:** Medical Devices Regulatory Affairs Strategy...Medical Device Directive & European Union Medical Device Regulation, FDA regulatory … more
- Wolters Kluwer (Chicago, IL)
- …portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important ... activities, including verification and validation. + Lead resolution of quality issues with on-market device software; drive... regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP.… more
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