Regulatory Affairs Specialist; FDA medical device regulation

Position: 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:

** 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 environmentor

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…