Senior Submissions Coordinator

Fujifilm • Durham, NC

1d • Onsite

About The Position

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.

Requirements

• Bachelor's Degree required.
• 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.

Nice To Haves

• Bachelor’s degree in computer science, Software Development, Information Technology or similar preferred.
• Prior knowledge with HCUS MI products is a plus.

Responsibilities

• Prepare and submit technical documentation to agencies such as the FDA or European regulatory agencies, ensuring completeness, accuracy, and compliance.
• Develop and maintain detailed Software Requirements Specification to meet internal and regulatory needs.
• Facilitate the creation, creation, or maintenance of Software Architecture and Software Design Specifications (SDS) in coordination with Design and Development teams.
• Create and maintain performance data in conjunction with AI Developers for regulatory needs.
• Create and maintain Technical Documentation required by EU MDR - Regulation (EU) 2017/745, U.S. FDA, and other regulatory regions.
• 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.
• Manage submission projects, including creating and managing project schedules and task details.
• Ensure submission projects stay on schedule, track and support multiple simultaneous projects, keep stakeholders appraised of status and issues, perform risk analysis, and create risk mitigation strategies.
• Work with and manage cross-functional projects simultaneously.
• Liaise with the HCUS RA/QA department to ensure open communication and assist with all RA/QA needs relating to the Company’s software registration, regulatory-related audits, and other issues.
• Stay updated on evolving regulations and ensure organizational adherence to these standards.
• Maintain meticulous records and facilitate communication between the organization and regulatory bodies.
• Strategize regulatory pathways and manage 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.
• 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.

Benefits

• The Company encourages vaccination against COVID-19.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior