This position is intended to provide Regulatory Affairs support to FUJIFILM Medical Systems U.S.A., Inc. 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.

Duties and responsibilities

• 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.
• Prepare European Union Technical Files and International Regulatory Submissions.
• Coordinate Import/Export/Customs activities.
• Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records.
• Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records.
• Coordinate all Mandatory Field Notifications, Engineering Change Orders, 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.
• Perform Internal Audits and External Supplier Audits.
• Coordinate U.S. FDA remediation activities.
• Prepare Management Review Meeting presentations.
• 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 Degree highly preferred.
• Three (3) or more years of hands on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment.
• Deep 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.
• Deep 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.