Regulatory Affairs Specialist (FDA medical device regulation)

Company Overview At FUJIFILM Healthcare Americas Corporation, we’re on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics. But we don’t stop at healthcare; our Non-Destructive Testing (NDT) team harnesses advanced radiography solutions to keep transportation infrastructure, aerospace, and oil and gas assets safe and running smoothly. Ready to innovate, collaborate, and make a difference? Join us and bring your big ideas to life while working in a dynamic, flexible environment that fuels your creativity and drive. Our headquarters is in Lexington, Massachusetts, an inspiring healthcare research hub in a historic town. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Overview This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation. This position supports full, ongoing compliance to 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. External US Duties and responsibilities Designated Responsible Personnel for Device Marketing Authorization and Facility Registration to include proper registration, listing, licensing, notification and approval information submission to regulatory authorities or authorized representative participating in the Medical Device Single Audit Program (MDSAP) (ISO 13485/MDSAP) Designated Joint Responsibility pursuant of Article 15 of the European Union Medical Device Regulation (EU MDR (EU) No. 2017/745) Perform Pre-Market U.S. FDA submissions (510(k) and PMA) in accordance with the product plan. Provide feedback and recommendations to design teams regarding deciding when to submit a 510(k) for a change to an existing medical device. Provide feedback and communicate the conclusion to business units regarding regulatory documentation of new product and supplier assessment. Prepare European Union Technical Documentation and International Regulatory Submissions. Evaluate all sources of incoming customer information, identify, investigate, and document escalated Customer Complaints, perform trend analysis and maintain all records. Confirm the Medical Device Reportability of - identified potential adverse events , take appropriate action and maintain all records. Coordinate Field Action Notifications, Risk Assessments, and Correction and Removals, take appropriate action and maintain all records. Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action. Perform Corrective and Preventive Action activities. Prepare QMS audit data Prepare documentation for remediation activities. Support Import/Export/Customs activities. Prepare Management Review Meeting data. 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 in related discipline and 2+ years of hands-on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment or Regulatory Affairs Certification and 4+ years of hands-on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment Broad 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. Broad knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations). Excellent leadership, communication, collaboration, team work and interpersonal skills. Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external). Excellent computer and internet search skills. Strong ability to multi-task and to meet business deadlines. Excellent organizational skills with an ability to think proactively and prioritize work. Physical requirements The position requires the ability to perform the following physical demands and/or have the listed capabilities: 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. #LI-Remote 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 ([email protected] or (330) 425-1313).