- Danaher Corporation (Brea, CA)
- …challenges. The Senior Quality Assurance Scientist for Beckman Coulter Diagnostics is responsible Post Market Surveillance Reporting . This position is ... have the opportunity to: + Perform Evaluation of Documentation Management with a focus on Post Market Surveillance Reporting . + Lead Post Market … more
- ZOLL Medical Corporation (Chelmsford, MA)
- …assess gaps in the Quality Management System as it relates to Post Market Surveillance . + Ensure reporting requirements are compliant with ZOLL Policy ... to an effective Post Market Surveillance program. + Provide support for annual reporting... reporting , CER's, and PMA activities related to Post Market Surveillance . + Stay… more
- Philips (Colorado Springs, CO)
- …role** + Learn and support global Post Market Surveillance including complaint intake, investigation, Vigilance reporting , record review, record closure, ... **Intern - Quality, Post Market Surveillance - Colorado Springs, CO - Summer 2025** Are you interested in an Internship opportunity with Philips? We welcome… more
- Teleflex (Chelmsford, MA)
- …* Provide regulatory review for reporting activities required by EU MDR (ie post - market surveillance , reporting , etc.). * Review and approve all ... Labeling (product, advertising and promotional) and ensure claims are substantiated. * Assist in regulatory due diligence process as needed. * Proactively drive RA project deliverables by collaborating cross-functionally and engaging with cross-business unit… more
- Teleflex (Morrisville, NC)
- …* Provide regulatory review for reporting activities required by EU MDR (ie post - market surveillance , reporting , etc.). * Review and approve all ... labeling (product, advertising and promotional) and ensure claims are substantiated for all classes of classes. * Assist in regulatory due diligence process as needed. * Proactively drive RA project deliverables by collaborating cross-functionally and engaging… more
- Integra LifeSciences (Princeton, NJ)
- …what's possible and making headway to help improve outcomes. The Quality Engineer II, Post Market Surveillance is directly responsible for the development of ... Safety Update Reports (PSURs) for Integra's Class II and Class III Medical Devices and Post Market Surveillance Reports (PMSRs) for Integra's Class I, and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …@Olympus.com, it is likely not legitimate._ **Job Description** The Global Director of Post Market Surveillance Service Strategy & Programs is responsible ... for leading the optimization of the Global Post Market Surveillance Service BPO...CFR 820.198 (Complaint Handling) and 21 CFR 803.3 (MDR Reporting ), aligning with company goals. + Leadership and Team… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** The Post Market Surveillance Manager - Medical Events Team ... of world for the division's products. Is proficient with medical event reporting and complaint handling policies and procedures. Manages staff to evaluate… more
- LSI Solutions (Victor, NY)
- …status of regulatory submissions and perform duties related to regulatory post - market surveillance , and vigilance reporting ; 5) read and interpret ... MDR Article VII and Annex XIV and proficient with post - market requirements. + If assigned to the...and tracking. + Knowledge of domestic and international vigilance reporting requirements for medical devices. + Love of Learning… more
- TD Bank (New York, NY)
- …team of compliance professionals responsible for overseeing, reviewing and enhancing the surveillance program for the market abuse and electronic communications ... filings, providing relevant training, carrying out independent monitoring and oversight activities, reporting on the state of compliance to the Board, UDP and senior… more
- Taiho Oncology (Princeton, NJ)
- …should have extensive knowledge of ICH/FDA/EMA guidelines for GCP and Clinical and post -marketing Safety Reporting . + Highly developed skills in verbal and ... Sr. Director, PV Medical Surveillance Princeton, NJ, USA Req #378 Monday, July...analysis of safety data from clinical trials and from post -marketing sources, providing medical expertise to assigned project teams,… more
- GE HealthCare (Wauwatosa, WI)
- …+ GE HealthCare Product-specific knowledge - Ultrasound. + Quality, Regulatory, or Post Market experience preferred. + Demonstrated knowledge of ISO 13485, ... Summary** Uses clinical product knowledge combined with skills in Product Surveillance to handle complaints, support regulatory reporting , and establish… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …in Vigilance Process and Reporting , Correction and Removal Processes, and/or Post - Market Surveillance . + 3+ years of managerial experience also ... with direct responsibility for review and approval of Incident reporting decisions in the US. Responsible for the management...local regulations (FDA/ANSM). + Contribute to the completion of Post Market Surveillance (PMS) reports… 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
- Terumo Medical Corporation (Somerset, NJ)
- …priorities. 10. Manage preparation and reporting of quality data for purposes of Post Market Surveillance and as the primary input into the Management ... 3940 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Post Market Surveillance Terumo Medical Corporation (TMC) develops,… more
- Philips (Pittsburgh, PA)
- …will learn the regulations and requirements of medical device companies regarding post market surveillance , lead different performance improvement projects, ... **Your role:** + Build capabilities and knowledge in the Post Market Surveillance space with...the primary representative for the Complaints Handling and Vigilance Reporting teams for data inquiries or data driven projects… more
- AbbVie (Branchburg, NJ)
- …including Quality Index, Site Business Review, Quality Systems Management Review, and Post Market Surveillance Review. + Provide in-depth insights ... a data-driven culture within our quality organization and site, reporting directly to the Executive Director of quality. As...above-site reviews when required. Own and maintain procedures for Post Market Surveillance , Quality Management… more
- Danaher Corporation (Chaska, MN)
- …event reporting and vigilance reporting . This position is part of the Post Market Surveillance (PMS) team and is an onsite position in Chaska, ... lives with diagnostic tools that address the world's biggest health challenges. The Manager Post Market Vigilance ( Post Market Quality) for Beckman… more
- BeiGene (Emeryville, CA)
- …+ Accountable for output/summary report for inclusion into clinical, filing, and post - market reports + Accountable for daily, weekly, and monthly review ... updates of safety presentation content **Developmental Product Safety Monitoring and Surveillance (Protocol Specific):** + Accountable for the analysis of SAEs by… 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 ... with R&D, Global Strategic Marketing, Commercial, and HEMA (Health Economics and Market Access). This role will also provide strong input on long-term product… more