Senior Submissions Coordinator

Position Overview This position is intended to provide technical documentation and Submissions expertise and support to all FUJIFILM Healthcare Americas Corporation (HCUS) business sites. A Submissions Coordinator plays a crucial role in ensuring that products meet regulatory standards and facilitates the submission process to regulatory agencies such as but not limited to U.S. Food and Drug Administration (U.S. FDA) and European regulatory agencies under the EU Medical Device Regulation (EU MDR) – Regulation (EU) 2017/745. This position provides technical documentation as required by U.S. Food and Drug Administration (U.S. FDA) and European regulatory agencies under the EU Medical Device Regulation (EU MDR) – Regulation (EU) 2017/745. As a Senior this position will lead and manages projects that aim to be submitted to U.S. Food and Drug Administration (U.S. FDA) and European regulatory agencies under the EU Medical Device Regulation (EU MDR) – Regulation (EU) 2017/745. Duties and Responsibilities Document Preparation and Submission: The coordinator is responsible for preparing and submitting technical documentation to agencies such as the FDA or European regulatory agencies. This includes ensuring that all submissions are complete, accurate, and compliant with applicable regulations. Document Preparation: Develop and maintain detailed Software Requirements Specification that is required to meet internal and regulatory needs. Facilitate the creation, create or maintain Software Architecture and Software Design Specifications (SDS) in coordination with the Design and Development teams. SDSs must meet internal and regulatory needs. Create and maintain performance data in conjunction with AI Developers that is required to meet regulatory needs. Create and maintain Technical Documentation required by EU MDR – Regulation (EU) 2017/745, U.S. FDA and other regulatory regions. Submission: Coordinate and complete U.S. FDA pre‑market submissions (510(k) and PMA) in accordance with the HCUS business plan. Maintain the U.S. FDA database for Establishment Registrations and Device Listings for all FUJIFILM business entities. Coordinate and complete submissions under the EU MDR – Regulation (EU) 2017/745 in accordance with the HCUS business plan. Prepare European Union Technical Documentation and International Regulatory Submissions. Provide support for International Registrations, as needed. Submission Projects: The Senior Submissions Coordination is responsible for managing submission projects. This includes: Create and manage the project schedule and task details. Ensure the submission projects stay on schedule. This individual must be able to track and support multiple simultaneous projects, keep all stakeholders appraised of status and issues, perform risk analysis and create risk mitigation strategies. Ability to work with and manage cross functional projects simultaneously. Cross‑Department Collaboration: A submission coordinator works closely with various departments, including research and development, quality assurance, regulatory, and legal teams, to gather necessary information and ensure compliance throughout the product lifecycle. Liaise with the HCUS RA/QA department to ensure that there is open communication and to assist with all RA/QA needs relating to the Company's software registration, regulatory‑related audits, and other issues that arise from time‑to‑time. Compliance Monitoring: The coordinator must stay updated on evolving regulations and ensure that the organization adheres to these standards. This involves maintaining meticulous records and facilitating communication between the organization and regulatory bodies. Risk Management: The coordinator plays a role in strategizing regulatory pathways and managing risks associated with product approvals and compliance. Coordinate U.S. Import/Export/Customs related activities. Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action. Support and provide evidence for Internal Audits and External Audits. Create and/or update Standard Operating Procedures and Work Instructions. Perform Corrective and Preventive Action activities as assigned. Attend all department and company‑wide team meetings as needed. Other duties as assigned. Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards. Qualifications Bachelor's Degree required. Bachelor's degree in computer science, Software Development, Information Technology or similar preferred. Experience documenting complex Software Systems. Prior experience as a developer, quality assurance technical writer for MI products or project coordinator/manager. Five (5) or more years work experience in Medical Informatics or Software related industry. Understand medical imaging terminology, workflow, and its relationship with HCUS products. Three (3) or more years of hands‑on experience working in a regulated environment and supporting the Regulatory Affairs department. Excellent project management, communication, collaboration, teamwork, interpersonal, problem solving and critical thinking skills. Understand Software terminology and techniques with the ability to translate software concepts to meet regulatory needs. Expert and Strong computer skills Microsoft project management application (Excel, Word, PowerPoint, TFS, MS Project, etc.). Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations. Knowledge of international medical device standard requirements (ISO 13485 / ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations). Excellent written and verbal communication skills. Strong ability to multi‑task and to meet business deadlines. Excellent organizational skills with an ability to think proactively and prioritize work. Prior knowledge of Medical Informatics Medical Devices (Software Devices) Ability to learn and master new software products. Prior knowledge with HCUS MI products is a plus. Physical Requirements The ability to sit up 75‑100% of applicable work time. The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time. The ability to stand, talk, and hear for 75% of applicable work time. The ability to lift and carry up to ten pounds up to 20% of applicable work time. Close Vision: The ability to see clearly at twenty inches or less. Travel Occasional (up to 25%) travel may be required based on business need. COVID‑19 Vaccine Requirements In the event that COVID‑19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID‑19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. Applicants to positions where vendor credentialing or other similar requirements exist to enter facilities will be required to comply with the credentialing requirements of the facilities, including complying with vaccine requirements. For all positions, the Company encourages vaccination against COVID‑19 and requires that the successful candidate hired be willing to test for the COVID‑19 virus periodically and wear a face covering indoors as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on click.appcast.io or (330) 425‑1313). #J-18808-Ljbffr Merck & Co. Inc