- Abbott (Maple Grove, MN)
- …clinical evidence including data from sources such as clinical investigations, literature, post- market surveillance , risk, and post market clinical ... evaluations. Analyzes results in preparation for product applications and submissions. + Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes. + Supports additional clinical, regulatory, quality and… more
- Bausch Health (Bothell, WA)
- …assessment of product changes. + Prepare and submit regulatory documents for post- market surveillance , including annual reports, and other required documents. ... role: Product Lifecycle Management + Oversee the regulatory aspects of post- market activities such as changes, modifications, enhancements, renewals, and lifecycle… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …strategy + Work with sales, marketing, and quality/complaint handling teams for post- market surveillance + Drive technical root cause investigations, engaging ... track record of leading complex medical device development from concept to market + Strong knowledge of regulatory requirements and quality standards in the… more
- R3 Strategic Support Group, Inc. (Fort Belvoir, VA)
- …white papers, and presentations related to CWMD technologies. + Assists with market surveillance of emerging technologies with potential CWMD applications. + ... Liaisons with various CWMD stakeholders in the special operations community, industry, and academia. + Travels occasionally within the United States and overseas, as required. Qualifications: + TS/SCI security clearance eligibility required. + Joint or… more
- Stryker (Houston, TX)
- …medical and nursing staff Interacts with customers with regard to post market surveillance activities. -Responsible for staying current with all ComplianceWire ... training with none past due. -Other duties as assigned by manager. -Has the independence and authority to perform required tasks to ensure all provisions of the quality system are met. **PHYSICAL REQUIREMENTS** -Heavy work: Exerting up to 50 pounds of force… more
- Genentech (Hillsboro, OR)
- …perform product complaint assessments and or investigations, and other related post- market surveillance activities. + You will conduct process investigations ... and root cause analyses to identify and address deviations, non-conformances, and other process-related issues, implementing corrective and preventive actions as necessary. + You will utilize Lean Production System elements and methods to continuously improve… more
- Merck (Rahway, NJ)
- …all phases of the product lifecycle, from concept through launch and post- market surveillance . **Key Responsibilities and Activities:** The Senior Scientist, ... Device System - Device Design Control will be responsible for device design control activities in the following aspects: + Lead and contribute device development design controls for the assigned projects. + Prepare materials for program presentations for… more
- J&J Family of Companies (Santa Clara, CA)
- …Risk Management Plans and Reports. + Perform periodic review and update of Post Market Surveillance data to ensure it is aligned with Product Risk Management ... Files. + Oversee Design Verification and Validation Testing. + Lead/coordinate/perform verification/ validation activities for: + Biocompatibility Testing. + Packaging Validation. + Accelerated and Real Time Shelf-Life/Aging Studies. + Sterilization… more
- Integra LifeSciences (Cincinnati, OH)
- …not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance , Nonconforming Materials, etc. + Fulfill design control ... requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines + Support Design and Technical… more
- Philips (Colorado Springs, CO)
- …Management is effective utilizing feedback from validation, field service, post market surveillance , manufacturing indicators, CAPAs, HHAs, etc. Expertise in ... ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software. + Serving as SME for Software Design Assurance and collaborate with teams on code review, unit tests, software security analysis, defect and vulnerability triage, creation… more