Oracle, headquartered in Austin, Texas, is a global leader in computing solutions. The company specializes in database management systems, cloud-engineered systems, and enterprise
Post Market Surveillance Coordinator
Location
United States
Posted
1 day ago
Salary
$87K - $178.1K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Post Market Surveillance Coordinator
Oracle
Role Description The Post-Market Surveillance Coordinator supports the ongoing monitoring, evaluation, documentation, and escalation of product performance and safety information after launch. This role helps ensure that post-market signals are captured, assessed, and tracked, in accordance with regulatory requirements and internal procedures as part of the quality system. - Manage and coordinate analysis of post-market product feedback, complaints, adverse events, incidents, field reports, and other safety or performance issues for trend analysis and PMS reporting obligations. - Lead a review of post-market surveillance processes and drive continual process improvement to maintain compliance with global market requirements. - Work primarily with the Oracle Health & Life Sciences business units and interact with all Oracle business units selling products to the health and life sciences industries. - Be collaborative, a creative problem solver, and dedicated to excellence in work. Qualifications - BA/BS or advanced degree preferred. - 6+ years' experience in quality systems, post-market signaling, real world evidence tracking, regulatory reporting (or 4+ years with Master's). - Experience acting as a lead to resolve issues. - Demonstrated critical thinking skills focused on improved system performance outcomes and positive impact. - Excellent problem-solving skills; demonstrated application of structured problem-solving methods and tools. - Experience leading process development. - Expertise in continual improvement and risk management. - Experience with advanced root cause analysis methods. - Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. - Experience authoring submissions (510k, EU Technical Documentation, etc.) required. - Experience with sustaining and new product development is ideal. - Experience interacting with regulators preferred. - RAC, CQE, CPPS, or CQA certifications desired. - Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, IEC 62304, 21 CFR parts 210, 211, 803, 820, or other quality system regulations. - Excellent written and verbal communication skills. - Ability to adjust and adapt to changing priorities in a dynamic environment. - Ability to perform in a fast-paced and continually evolving business environment. Benefits - Flexible medical, life insurance, and retirement options. - Opportunities for community engagement through volunteer programs. Company Description Oracle's Healthcare and Life Sciences business is a global leader in industry-specific software and solutions to healthcare providers, payers, pharmaceutical companies, medical device companies, and clinical research organizations. We offer a range of products and services, including AI/ML solutions, cloud-based healthcare platforms, data analytics, electronic health records (EHR), and patient engagement systems. - Aims to help organizations improve patient outcomes, lower costs, and accelerate innovation. - Enables secure and compliant handling of sensitive healthcare data, helping organizations meet regulatory requirements and protect patient privacy. - Focuses on digital transformation to empower the industry to embrace modern technologies and improve overall healthcare delivery.
Related Guides
Related Categories
Related Job Pages
More Administration Jobs
Procore Administrator
RelatedRelated Affordable spearheads Related's initiatives to preserve and enhance the nation's affordable housing supply. With over 50 years of experience in affordable housing acquisitions and development, Related Affordable is renowned nationally for its financing, preservation, and rehabilitation innovation. Presently, Related Affordable manages one of the largest affordable housing portfolios in the United States. Our team is committed to the principle that everyone deserves a quality home, and we tirelessly strive to fulfill this mission in communities nationwide. We are proud to be an equal-opportunity employer committed to building an inclusive culture with competitive compensation aligned with experience and market standards.
Role Description The Procore Administrator – Construction & Development is responsible for supporting project teams by entering, maintaining, and managing project data within Procore. This role ensures accurate and timely data entry across key modules and provides day-to-day support to construction and development teams to keep projects organized, compliant, and running efficiently. This position serves as a central support resource for Procore system usage, user management, and reporting. - Enter and maintain project data within Procore, including: - Submittals - Drawings and document control - RFIs and other project records - General project documentation - Ensure all project information is accurate, complete, and up to date - Maintain organization and consistency of documents and data across projects - Assist project teams with tracking and managing workflows within Procore - Coordinate with: - Project Managers, superintendents, and development teams - Trade partners / subcontractors - Support communication and data flow between internal teams and external partners - Procore System Administration: - Create and manage user accounts and permissions - Maintain project setups, folders, and document structures - Generate and distribute reports as requested by project teams and leadership - Support onboarding of new users to Procore - Provide day-to-day troubleshooting and support for Procore-related issues - Assist teams with proper use of Procore tools and workflows - Identify and help resolve data inconsistencies or system issues Qualifications - Experience working in Procore is required - Experience supporting construction or development teams is required - Strong attention to detail and organizational skills - Ability to manage multiple projects and priorities simultaneously - Strong communication skills and ability to work across teams - Comfortable working with large volumes of documents and data - Proficiency in Microsoft Excel and general computer systems - Ability to learn and support new processes and tools quickly Requirements - Occasional travel may be required based on business needs - This role may be 100% remote, with the option to work from our Dallas office Company Description Related Digital is a leading vertically integrated data center development and investment platform. We deliver digital infrastructure solutions to hyperscale technology companies so they can accelerate artificial intelligence and cloud computing ambitions. Founded by Related Companies, one of the most prominent, privately-owned real estate development firms in the United States, Related Digital uniquely combines Related’s 50-year+ history of executing complex real estate and infrastructure projects with its track record in real estate investing and clean energy solutions. With a multi-billion-dollar, near-term development pipeline in the U.S., Related Digital has the expert capabilities, depth of expertise and national scale to help hyperscale companies significantly grow their data center capacity on a rapid timeframe. - Strategic Advantage: Related Digital harnesses expertise across real estate development and investment, data center development, complex infrastructure construction and clean energy development to bring differentiated solutions to hyperscale technology companies. - National Footprint: Related Digital is based in New York and Dallas with operations across the United States. Related Companies has offices in gateway cities across the U.S. and London, and developments in 28 states and the District of Columbia, and boasts 4,000 employees.
Retirement Administration Specialist
Franciscan HealthBased in Indiana, Franciscan Health is one of the Midwest's largest Catholic healthcare systems. Founded in 1876, the nonprofit organization was named one of Truven Health Analytic
• Administer the daily administration of 401(k), 403(b), 457(b), 457(f) and defined benefit plans • Request benefit calculations from the plan actuary and prepare appropriate paperwork • Inform prospective retirees about their Defined Benefit (DB) options • Research plan overpayments, requests stop payment/reissues ACH reversals and follows up with participants or participant's survivor • Research, communicate and complete cases in electronic case management system consistently within the Service Level Agreement assigned • Educate active and inactive coworkers and beneficiaries on vesting, plan participation, payment options and other retirement details • Provide support to business HR team members, coworkers, and retirees
Role Description Working under the general supervision of the Vice President of Client Experience, referring only exceptional problems and issues for management review or approval, the Client Experience Project Administrator serves as a liaison between the Enterprise Sales Teams, the clients, the partners, and the project managers. The Administrator organizes and coordinates product delivery, maintains updates on timelines and project statuses, and prepares any reporting required by the client. The Administrator, demonstrating agility and flexibility, coordinates all efforts as needed for last minute product or delivery changes while keeping the client, sales team, and all necessary personnel updated on the status. Where applicable, this position assures departmental processes are performed in compliance with applicable Sarbanes-Oxley controls. - Serves as direct contact between partner, PM, PMO office, Sales, Sales Operations, and clients to coordinate all business requirements - orders, SLAs, projects, reports, pre and post account management, communication. Manages inquiries and escalations. - Works with Project Manager and Client Experience stocking team to manage product needs, availability, and delivery. - Manages all aspects of the product delivery including tracking, scheduling deliveries, and managing returns back to partner warehouse. - Directly engages, schedules, and follows up with service partners for project work. - Works with Client Experience and IAM on RMA and DOA products and coordinates order fulfillment for replacements. - Validates the data and coordinates delivery of all required client reports. - Prepares reporting by validating key data points; coordinates delivery of all required client reports. - Provides daily shipping report for tracking, serial numbers, and asset tags as applicable. - Provides weekly inventory report with totals in the partner warehouse with details on status of product. - Works with Enterprise Sales team and distribution partner on order fulfillment and status updates for all client orders in configuration lab or at a distribution partner. - Works with TIDC team and Product Management team on order fulfillment and status updates for all customer orders in configuration lab or at a distribution partner. - Requests SKU creation and enters orders for spare parts as needed. - Arranges delivery requirements as specified in project documents and addresses delivery issues. - Works with Sales team to problem solve scheduling conflicts. - Participates in customer conference calls to define services and schedules. - Ensures project coordination teams are keeping all parties informed of status of current projects. - Provides management with input regarding improvement opportunities. Qualifications - Degree requirements: Associate's Degree or the equivalent combination of education and work experience. - Minimum years of work experience to qualify for role: 9. - Total years of work experience to be fully proficient: 11. - Intermediate to advanced Excel skills with ability to create charts, subtotals, pivot tables, etc. - Working knowledge of Traxx/MarkITPlace enterprise system with ability to maintain orders and read ETA dates from vendors required. - Working knowledge of applications used to manage and track value added services activities. - Intermediate to advanced working knowledge of Microsoft Office suite (Outlook, Word, Access, PowerPoint, etc.). - Understanding of the lifecycle of a customer order with some order processing experience. - Knowledge of Enterprise sales organization and sales process. - Understanding of Supply Chain Management process. - Demonstrated knowledge of the project coordination process, including a clear understanding of the role played by each team. - Organized with ability to multitask with competing priorities and deadlines. - Excellent communication skills with ability to converse in a professional manner with customers, ask difficult questions that are critical to project success, and question answers provided by production resources. - Detail oriented with ability to drill down several layers to get the core issues. - Flexible in adapting to changing conditions and priorities. - Reliable with ability to perform the duties of the role in the time required. - Excellent reasoning and comprehension skills with ability to understand and follow complex directions. - Strong skills to anticipate and manage customer expectations by gathering information and executing in a rapidly growing, fast-paced environment, this includes pre-sales, during the sale process, and post-sale activities. - Learning agility to increase knowledge in all areas needed to be successful in this role. - Organized with ability to multitask with competing priorities and deadlines, while keeping stress level at a minimum. - Ability to document procedures and train others. - Ability to consistently present Connection in a positive professional manner to our customers. Requirements - Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. Benefits - Supportive teammates and a rewarding career. - Progressive and competitive compensation, 401k plans, and medical insurance. - Free therapy visits, mental health coaching and tools, and meditation resources. - Generous paid time off package that includes vacation, sick time, Wellness and Volunteer Time Off days.
Grants Administrator
Satellite OfficeGreat Place To Work® Philippines Certified | 2024 FT Fast 100 - Ranked 60th
• Provide high-level administrative support to the Grants Team • Maintain and update team calendars, schedules, and meeting logistics • Assist with document preparation, formatting, and distribution • Maintain accurate records of grant applications and funding approvals • Liaise with internal stakeholders and respond to routine queries • Assist with tracking funding compliance documentation



