- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... & Johnson is hiring for a **Sr. Manager, Regulatory Compliance - Shockwave Medical ** to join our... to manage risk and ensure a strong regulatory compliance profile. Assures quality and compliance… more
- Caldera Medical (Westlake Village, CA)
- …engineering, Life Sciences, or a related technical field. - 10+ years of experience in medical device Quality , including leadership roles. * Minimum of 5 ... of the Quality Management System (QMS), ensuring alignment with global medical device regulations such as ISO 13485, while leading reporting efforts… more
- Abbott (Alameda, CA)
- …+ Must have 5+ experience in Software Quality Assurance. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part ... History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. + Develops… more
- AbbVie (North Chicago, IL)
- …fosters regulatory compliance , and contributes to the overall success of drug/ device development programs. Associate Director, Safety, Medical & Regulatory ... Quality is part of the R&D Quality Medical Affairs (MA) QA team which...activities. The role covers AbbVie's entire portfolio of drug, device and cosmetics. The role ensures quality … more
- Terumo Medical Corporation (Elkton, MD)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...production and project activities and drive continuous improvement. Ensure compliance to TerumoA cents € (TM) s quality… more
- J&J Family of Companies (Irvine, CA)
- …Degree is preferred. + A minimum of 8 years of combined experience in Regulatory Compliance and/or Quality in Medical Devices or pharmaceutical products is ... authority trends that enable the organization can deliver on quality and compliance commitments. Develop proactive approaches...required. Medical Device experience is preferred. + Strong knowledge of FDA… more
- Fresenius Medical Center (Waltham, MA)
- … compliance , quality engineering and auditing in the pharmaceutical or medical device sector or related industries + Several years of practical experience ... These core values are, Patients and Partners First, Honesty and Integrity, Quality and Compliance , Collaboration, No-Limits Mindset and Results Oriented.… more
- Danaher Corporation (Richmond, IL)
- …a minimum of three years' equivalent experience + Minimum of two years' experience within medical device /IVD. + FDA (Class I & II) and Health Canada regulatory ... actions. + Experience with ISO 13485:2016, IVD/MDR Regulations, FDA GMP and domestic/international Medical Device Regulations. It would be a plus if you also… more
- Globus Medical, Inc. (Audubon, PA)
- …with one to three years of healthcare compliance experience preferably with a medical device or pharmaceutical company. + Ability to thrive in a fast-paced, ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our... Compliance Associate contributes to strengthening the Globus Medical Compliance Program by promoting compliance… more
- Globus Medical, Inc. (Audubon, PA)
- …**:** + Bachelor's degree combined with at least 4 years of healthcare compliance experience with a medical device or pharmaceutical company. ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our... Compliance Specialist contributes to strengthening the Globus Medical Compliance Program by promoting compliance… more
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