- Abbott (St. Paul, MN)
- …- market phase of product life cycles. The individual will review/manage Post - Market Surveillance (PMS) Plans, Periodic Safety Update Reports (PSUR), ... and adverse event reporting. + Project management experience. + Experience in post - market surveillance , risk management, clinical research, or regulatory… more
- Stryker (Tempe, AZ)
- …**Stryker** is hiring a ** Senior Engineer, Post - ... and direction in quality assurance, complaint handling, investigations, and support post - market product surveillance activities. Drive preventative… more
- Zimmer Biomet (Warsaw, IN)
- …and post - market surveillance + Trains and supports Zimmer Biomet Post Market Surveillance and Quality team with product investigations + May ... location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment… more
- Olympus Corporation of the Americas (Westborough, MA)
- …work on IP specific activities the IPL will participate in standing committees, review post market surveillance trends, perform due diligence reviews, and ... new product development processes, R&D engineering, risk management, clinical trials, post - market safety surveillance , health hazard assessments and… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …files, Product Development Process, assessment for potential adverse events, field actions and Post Market Surveillance , as well as compliance with Corporate ... Position Summary: We are looking for a Sr . Director, Product Quality who will evolve within...to the Senior VP of Pre and Post Market Quality within a team of… more
- Terumo Medical Corporation (Elkton, MD)
- …to monitor product/process compliance to the most up-to-date requirements. + Collaborate with Post - Market Surveillance team to establish a robust process for ... Sr . Quality Compliance Engineer Date: Jun 13, 2024 Req ID:...overseeing the management of all post - market sustaining activities required to maintain… more
- Philips (Pittsburgh, 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
- 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
- Teleflex (Wyomissing, PA)
- …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:** May 28, 2024...make a difference in patients' lives. **Position Summary** The Sr . Regulatory Affairs Specialist (SRA) will develop US, EU,… more
- Zimmer Biomet (Warsaw, IN)
- …submission and post - market surveillance . * Train and support Post Market Surveillance and Quality team with product investigations. * Serve ... location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment… more
- Philips (Cambridge, MA)
- …in a regulated industry. 5+ years working experience in product development or post - market surveillance (in medical device for medical businesses). 5+ ... ** Senior Global Product Risk Manager** The Senior...a strong background in FMEAs. Knowledgeable about Complaints and Post - Market Surveillance connections with Product… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …standards throughout the product lifecycle, including design, development, testing, and post - market surveillance . + Support regulatory submissions and ... should have the ability to coach, mentor, as well as, work closely with senior management to advance agility at the enterprise level. We would like someone who… 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
- Danaher Corporation (Austin, TX)
- …outputs are meeting our quality and regulatory standards. This position is part of the Post Market Surveillance department located in Brea, CA and will be ... tools that address the world's biggest health challenges. The Senior Staff Global Process Owner Quality Assurance for Beckman...and implement tactical plans to meet Beckman Coulter and Post Market Surveillance objectives and… more
- GRAIL (Menlo Park, CA)
- …and safety risk management for all GRAIL products during the product development and post - market surveillance phases. This leadership role will be within the ... Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com . The Sr . Director, Medical Safety will lead the development and implementation of a… more
- Taiho Oncology (Princeton, NJ)
- Sr . Director, PV Medical Surveillance Princeton, NJ, USA Req #378 Wednesday, June 12, 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
- Academy Sports + Outdoors (Katy, TX)
- …for resolution. + Maintains database of relevant product incident information; analyzes post -performance/ market surveillance data to determine trends in ... safety and quality issues. + Leads stakeholders, including merchant team, stores, and distribution centers through product compliance investigations, actions, recalls, and other related matters. + Monitors regulatory compliance developments/trends and assesses… 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 Structural Heart Clinical Evaluation… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Device preferred). + Strong prior experience in Quality Assurance initiatives including post market surveillance , complaints management, quality KPls, Design ... our core values by staying **True to Life.** **Job Description** The Sr . Manager, Business Development Quality Assurance will support Quality Assurance M&A… more
- UL, LLC (Chicago, IL)
- …certifications/processes. + Provide regulatory support for product lifecycle management, including post - market surveillance and reporting. + Develop and ... Summary: As a Global Market Access Expert, you will be responsible for...for developing and implementing strategies to obtain and maintain market access requirements and information. You will work closely… more