- Merck & Co. (Rahway, NJ)
- …definition through commercialization to support regulatory filing, product launch, and post - market surveillance .This position will interact with ... formal authority; ability to influence and present ideas to senior leadership-Excellent communication, presentation, negotiation, project management, and organizational… more
- Arthrex (Naples, FL)
- …and driving Design Assurance principles within engineering teams for design, development transfer and post - market surveillance of FDA Class I and II, EU ... development and medical education in orthopedics. Arthrex is actively searching for an Engineer Sr II - QA Design for our global headquarters in Naples, FL. The … more
- 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
- Danaher Corporation (Brea, CA)
- …The Senior Quality Assurance Scientist for Beckman Coulter Diagnostics is responsible Post Market Surveillance Reporting. This position is part of the ... will have the opportunity to: + Perform Evaluation of Documentation Management with a focus on Post Market Surveillance Reporting. + Lead Post Market … more
- Philips (Gainesville, FL)
- The Director-Global Data Analytics- Post Market Surveillance will oversee the strategic use of data to include operational activities used to effectively ... support post market surveillance activities, per...data collection and reporting activities + Reporting to the Sr Director-Global Data Analytics & Risk Management, you will… more
- Fresenius Medical Center (Knoxville, TN)
- …as a liaison between manufacturing facilities, distribution centers, customer/technical service, Post Market Clinical Surveillance and customers/patients ... + Applies basic knowledge of drug/device regulatory requirements in order to support Post Market Clinical Surveillance MDR/ADE reporting decision process 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 Mgmt Requisition ID: 66496...Management, including change controls, device complaint investigations, CAPAs, and post - market surveillance . + Regulatory Affairs… 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
- 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
- Danaher Corporation (Boulder, CO)
- …PMA, 510(k), de novo, technical files, pre-submissions, annual renewals, change notifications, post - market surveillance activities, etc. + Author and/or ... review regulatory documents for submission and global market entry providing regulatory expertise to team and effective communication to Sr . Leadership to ensure… more
- Actalent (Elkton, MD)
- …The Senior Complaints Quality Engineer will provide engineering support in post - market surveillance , with a focus on complaint investigations, product ... performance as part of Continuous Improvement. Hard Skills + Engineering support in post - market surveillance + Complaint investigations + Product evaluations… 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
- Danaher Corporation (San Francisco, CA)
- …510(k), de novo, technical files, pre-submissions, annual renewals, change notifications, post - market surveillance activities, etc. Provide guidance, ... with less experience. + Author and/or review regulatory documents fo r global market entry , Design History Files, and perform regulatory activities in support of… more
- ThermoFisher Scientific (Rochester, NY)
- …from different countries and regions. Work closely with Quality partners to ensure Post Market Surveillance and Vigilance reporting is completed. Supports ... will also be responsible for talent development within the team. Reporting to the Senior Director of Regulatory Affairs, the incumbent will serve as a member of the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of issues prior to release and any issues that may present from the post - market surveillance teams. + Quality representative in risk management activities ... a highly motivated, results-focused professional to join our team as a ** Senior ** **Quality Engineering Manager - Software** . The Quality Engineering Manager's… 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 (Westborough, MA)
- …device, pharmaceutical) required + At least 3 years relevant experience dealing with post market surveillance and QA activities (complaint triage, ... to develop the next generation of life-changing therapeutics. The Senior Quality Assurance Engineer for Cytiva is responsible for...with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance + Excellent… more
- J&J Family of Companies (Raynham, MA)
- … registration and throughout life cycle. + Work with Medical Safety and Post - Market Surveillance to assess, analysis and interpret events, complaints, ... Senior Director, Medical Affairs Orthopedics - 2406206569W **Description**...product development, including evidence generation and dissemination that drive market registration, access, and adoption. This role supports medical… more
- Kelly Services (Redondo Beach, CA)
- …+ Participate in Product Plan Development, Regulatory Strategy, Product Labeling, Risk Management, Post - Market Surveillance , and Post - Market ... **Title** : Regulatory Affairs Specialist ( Senior Level) **Pay** : $38-$50/hr depending on experience...Technical Files, Design Dossiers, GSPRs for CE Marking) and Post - Market Follow-Ups + Support FDA Regulatory Requirements… more
