- ZOLL Medical Corporation (Chelmsford, MA)
- …time to be a part of ZOLL!Job SummaryThis stakeholder opportunity resides in ZOLL's Post Market Surveillance program designed to meet FDA's Quality System ... Support, Service, and Regulatory Affairs. Involved in several aspects of Post Market Surveillance leveraging talents to demonstrate compliance with… more
- Olympus Corporation of the Americas (San Francisco, CA)
- …needed to support both local and global targets and objectives. + Work with the Post - Market Surveillance department to establish tools and methods needed to ... Senior Global MDR Submission is responsible for managing Market Quality- COE MDR team for the regulatory assessment...processing and submission of potential adverse events. The Manager, Sr . Global MDR Submission works closely with the Global… more
- Terumo Medical Corporation (Somerset, NJ)
- …3940 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Post Market Surveillance Terumo Medical Corporation (TMC) develops, ... Sr . Mgr Med Device Prod Complain Date: Nov...Engineering, Operations, Clinical, Medical Affairs and Regulatory Affairs on Post Market Surveillance strategy and… more
- West Pharmaceutical Services (Exton, PA)
- …global regulatory filings, information request responses, change notifications, and post - market surveillance reports/compliance reports. + Independently ... Sr . Specialist, Regulatory Project Management (Evergreen Posting) Requisition...Management, including change controls, device complaint investigations, CAPAs, and post - market surveillance . + Regulatory Affairs… more
- West Pharmaceutical Services (Exton, PA)
- …Analytical Labs, Supply Chain, and Operations in support of product development, launch, and post market surveillance activities. The incumbent will be a ... Sr Quality Engineer, Integrated Systems Requisition ID: 66823...(eg, Medical Device), including Product Development, Product Manufacturing, and Post Market Surveillance Activities +… more
- Philips (New Kensington, PA)
- …on time tracking of open SCR Field Actions on a monthly basis + Support Post Market Surveillance group with Competent Authority requests + Collaborate with ... will be a Senior Corrections and Removals Specialist performing various Post Market functions related to recall reporting, tracking, and process execution.… more
- Fortive Corporation (Irvine, CA)
- …rework. + Applies Fortive Business Systems tools, as required. + Review customer complaints, post market surveillance , and market research for related ... **Position Summary:** The Sr . Reliability Engineer will be responsible for the reliability testing of Terminal Sterilization and High Level Disinfection equipment… more
- Teleflex (Chelmsford, MA)
- …projects. * Provide regulatory review for reporting activities required by EU MDR (ie post - market surveillance , reporting, etc.). * Review and approve all ... Sr . Regulatory Affairs Specialist **Date:** Nov 21, 2024...make a difference in patients' lives. **Position Summary** The Sr . Regulatory Affairs Specialist (SRA) will develop US, EU,… more
- Cordis (Irvine, CA)
- …Assurance and Manufacturing teams to implement improvements and prevent recurrence. + Report post market surveillance data Key Performance Indicators for ... who keep saving lives. We are seeking a proactive and detail-oriented ** Sr Product Performance Engineer** to support the manufacturing of high-quality medical… more
- Fresenius Medical Center (Lawrence, MA)
- …for the implementation of appropriate cybersecurity measures . Evaluation of events ( post - market surveillance ) within the scope of complaints/incidents and ... vulnerability management coordination of product related cybersecurity activities . Involvement in the definition of policies, SOPs and guidelines for cybersecurity and data privacy **Experience** . 2+ years of relevant experience in medical device… more
- AbbVie (Branchburg, NJ)
- …including Quality Index, Site Business Review, Quality Systems Management Review, and Post Market Surveillance Review. + Provide in-depth insights ... represent Branchburg in above-site reviews when required. Own and maintain procedures for Post Market Surveillance , Quality Management System Review, and… more
- Abbott (Westbrook, ME)
- …validation plans, listings and periodic review process. + Provide validation input to post market surveillance activities. + Present and communicate status, ... Take action to resolve disagreement prior to escalating for Senior management involvement. + Monitor and maintain the quality...analysis and design FMEA. + Provide design input to post market surveillance activities. +… more
- J&J Family of Companies (Cincinnati, OH)
- …plans and failure mode analysis during product development and safety signal detection and post - market surveillance post -launch. + Review and approve ... At Johnson & Johnson, we all belong. This position will report into the Senior Director, Medical Affairs and will provide medical leadership globally to Johnson and… more
- Edwards Lifesciences (Irvine, CA)
- …role will partner closely with other downstream functions in THV including post - market surveillance , global complaint handling and engineering, marketing, ... with sustaining activities for commercialized products + Experience in post market investigations, complaint investigations, CAPA investigation, development… more
- Taiho Oncology (Princeton, NJ)
- Sr . Director, PV Medical Surveillance Princeton, NJ, USA Req #378 Monday, July 15, 2024 Looking for a chance to make a meaningful difference in the oncology ... on a transformative journey with Taiho Oncology as a Sr . Director, PV Medical Surveillance . At...analysis of safety data from clinical trials and from post -marketing sources, providing medical expertise to assigned project teams,… more
- Hologic (Newark, DE)
- Sr Manager, Post Market ...United States **Elevate Quality and Customer Satisfaction as Our Senior Manager, Post - Market Quality, Engineering ... and enhancing customer satisfaction? We are looking for a dynamic and experienced ** Senior Manager, Post - Market Quality, Engineering** , to join our… more
- Abbott (Santa Clara, CA)
- …summarizes clinical evidence including data from sources such as clinical investigations, literature, post - market surveillance , risk, and post market ... from routine fingersticks. **The Opportunity** The function of a ** Senior Medical Writer/Project Manager** supporting our Vascular Clinical Evaluation Products… more
- Philips (Cambridge, MA)
- …the design and product realization processes. + Ensures that appropriate quality, reliability‐and Post Market Surveillance (PMS) plans are made; to include ... The Senior Quality Engineer- Products and Systems is a...Performs independent technical assessment on product quality performance and post ‐ market product quality analysis to lead quality… more
- Kelly Services (Sunnyvale, CA)
- …changes. + Act as the lead for QMS/Compliance activities, such as audits, Post Market Surveillance , Nonconformances (NC), Corrective and Preventative Actions ... pioneer progress in the biotechnology realm. **Position title:** Regulatory Affairs Senior Specialist, Global Market Protection **Workplace:** Remote **Shift** :… more
- Stryker (Mahwah, NJ)
- …+ Perform regulatory reviews for technical documents such as clinical documents, post - market surveillance reports, and NC/CAPA + Maintain current ... prevent future issues. **What you will do** As the ** Senior ** **Re** **gulatory Affairs Specialist** for Market ...the ** Senior ** **Re** **gulatory Affairs Specialist** for Market Continuity, you will have an integral role in… more