- 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
- Hologic (Newark, DE)
- Sr Manager, Post Market Quality...United States **Elevate Quality and Customer Satisfaction as Our Senior Manager, Post - Market Surveillance ... and enhancing customer satisfaction? We are looking for a dynamic and experienced ** Senior Manager, Post - Market Surveillance ** , to join our team 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
- 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
- Actalent (Elkton, MD)
- …The Sr 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
- 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
- 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
- Olympus Corporation of the Americas (Center Valley, PA)
- …Management, HHAs and Field Actions, complaint handling, adverse event reporting, CAPA and Post Market Surveillance activities in support of HHA development ... and expert guidance for the HHA teams. + Collaborates with global/regional leaders on relevant HHAs and interacts with Legal and Compliance as required. + Supports HHA in internal and regulatory inspections. **Job Qualifications** **Required:** + Bachelor'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
- Edwards Lifesciences (Irvine, CA)
- …on implementing and optimizing quality engineering practices related to Complaints Evaluation, Post Market Surveillance and Risk Management while ensuring ... Lead complaints evaluation with cross functional team * Deliver Post Market Surveillance for commercially...to the business * Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and… 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
- Bausch + Lomb (Columbus, OH)
- …Adobe Acrobat, MS Project) + Knowledge of country regulations (med device and pharma), post market surveillance , ISO and IEC + Detail oriented with ... and change management. Responsible for regulatory compliance, regulatory intelligence surveillance and US regulatory licensing. **Responsibilities** + Proactively communicate… 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
- 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
