- Globus Medical, Inc. (Audubon, PA)
- …team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Stryker (Weston, FL)
- …classification, jurisdiction assessment, and risk mitigation planning. + Prepare and submit regulatory documentation (eg, FDA submissions, EU design dossiers) to ... We are currently seeking a **Staff Regulatory Affairs Specialist** to join our Mako and...is required. + 4+ years of experience in an FDA regulated industry required; preferably with medical devices. +… more
- Abbott (Plymouth, MN)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... Abbott is a global healthcare leader that helps people live more fully...to support Abbott customers. + May interface directly with FDA and other regulatory agencies if so… more
- Abbott (Alameda, CA)
- …on future actions. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies, ... Abbott is a global healthcare leader that helps people live more fully...levels with our new sensing technology. **The Opportunity** This ** Regulatory Affairs Manager - International Compliance Operations** will work… more
- University of Pennsylvania (Philadelphia, PA)
- … Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable ... NCI and the FDA , as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Specialist-CC is expected… more
- Philips (Chicago, IL)
- …on time. + Your skills include extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical ... **Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound)** The...proactive, strategic relationships with external stakeholders (notified Bodies, US FDA , Competent Authorities, etc.) to ensure that requirements are… more
- Sumitomo Pharma (Lincoln, NE)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
- Philips (Plymouth, MN)
- …right fit if:** + You've acquired 10+ years of experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical Device ... The Director, Regulatory Affairs will lead the Philips RespirTech InCourage...making. Build proactive, robust, strategic relationships with external stakeholders ( FDA , NBs, CAs, MedTech forums etc.) to influence and… more
- Sumitomo Pharma (Madison, WI)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- J&J Family of Companies (Santa Clara, CA)
- … regulatory requirements in the light of current guidance and FDA /International regulatory body field activity. **REQUIRED KNOWLEDGE, SKILLS, ABILITIES, ... Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where...Johnson & Johnson is hiring for a **Sr. Manager, Regulatory Compliance - Shockwave Medical** to join our team… more
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